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Harms | All participants underwent a comprehensive evaluation of their intra-oral hard and soft tissues at baseline and follow-up. At the 12-month (T3) follow-up period, there was no harm reported or observed as a result of either intervention, confirming their safety and tolerance. Furthermore, no participant was removed from... | PMC10803043 | ||
Discussion | tooth brush, bleeding, hyperplasia, ’s mouth, gingivitis, caries, tooth brushing, orthodontic | BLEEDING, DEMINERALIZATION, HYPERPLASIA, GINGIVITIS, CARIES, BLIND, COMPLICATIONS | To date, no long-term RCT designed to evaluate the impact of MT versus PT in an orthodontic population has been reported, while more recent studies have once again only reported short-term (<8 weeks) evaluations [A key requirement of any participant undergoing fixed appliance therapy is the need to maintain optimal ora... | PMC10803043 |
Conclusions | orthodontic | PLAQUE | No differences have been found between a manual and sonic-powered toothbrush in controlling plaque and gingival health in participants undergoing fixed orthodontic treatment in either the short term or long term. | PMC10803043 |
Acknowledgements | We would like to acknowledge the support of the staff within the Hospital in helping to facilitate this research. We would like to thank Colgate-Palmolive (USA), for helping to support funding for the trial. | PMC10803043 | ||
Author Contributions | Ama Johal (CRediT contribution not specified), Muftah Shagmani (Investigation-Equal, Methodology-Supporting, Writing – review & editing-Supporting), Ian Arad (Conceptualization-Supporting, Investigation-Supporting, Methodology-Supporting, Writing – review & editing-Supporting), Omar Alfuraih (Investigation-Supporting, ... | PMC10803043 | ||
Conflict of interest | The authors declare that there is no conflict of interest. | PMC10803043 | ||
Data availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10803043 | ||
References | PMC10803043 | |||
Background | knee osteoarthritis | KNEE OSTEOARTHRITIS | A randomized clinical trial assessing plasma rich in growth factors (PRGF) versus hyaluronic acid for knee osteoarthritis was published in 2012 (sponsor trial ID BTI-01-EC/07/ART). Evidence of misreporting was discovered following access to unpublished materials. In accordance with the principles of the Restoring Invis... | PMC9850713 |
Methods | Reanalysis was made possible primarily based on two unpublished study documents (original trial protocol and final report) obtained from the authors of the original publication. A call to action, calling on the authors to correct the original publication, was publicly issued. The involved ethics committee was repeatedl... | PMC9850713 | ||
Results | pain | SECONDARY | The efficacy of PRGF was not statistically different from hyaluronic acid for any prespecified primary or secondary efficacy outcomes. For the primary endpoint, the percent of patients on PRGF compared to hyaluronic acid with a decrease >40% in WOMAC pain subscale score was 5.4% higher; 95% confidence interval (CI) −10... | PMC9850713 |
Conclusions | This reanalysis of Study PRGF found no clinically or statistically significant benefit from PRGF compared to hyaluronic acid. The restoration of Study PRGF shows the urgency of important changes to trial reporting and oversight practices. In the future, timely access to all clinical trial documents is needed to minimiz... | PMC9850713 | ||
Trial registration | This is a RIAT project, whose original trial was approved and registered on 19 December 2007 by the Ethics Committee of the Basque Country, Spain, as BTI-01-EC/07/ART. | PMC9850713 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-022-07049-3. | PMC9850713 | ||
Keywords | PMC9850713 | |||
Background | KNEE OSTEOARTHRITIS | There is substantial concern within the scientific community about the profusion of incompletely reported and misreported studies. Projects such as the Restoring Invisible & Abandoned Trials (RIAT) initiative (In this article, we present the results of our RIAT reanalysis of a clinical trial on plasma rich in growth fa... | PMC9850713 | |
Methods | We reassessed the data of Study PRGF in accordance with the RIAT recommendations. To this purpose and apart from the involved published article, we used as principal sources the following documents: (1) full original protocol, (2) ethics committee approval resolution, (3) final study report (summary version). All of th... | PMC9850713 | ||
Interventions | ®, pain | INFILTRATION, INFILTRATED | Each included participant was randomized to receive infiltrations of the affected knee (3 injections on a weekly basis) with either PRGF-Endoret® (BTI) or hyaluronic acid (Euflexxa®, Copenhagen, Denmark). PRGF-Endoret® was prepared from autologous peripheral blood at each treatment visit by following subsequent steps o... | PMC9850713 |
Sample size | pain | Sample size calculation was initially stated in the protocol based on the original main outcome, the percentage of patients with a decrease >40% in the score in the WOMAC pain subscale at the final visit with respect to baseline (which is similar to a pain improvement >40%). Null hypothesis was set as no difference in ... | PMC9850713 | |
Randomization and blinding | INFILTRATION, INFILTRATING | A stratified randomization in blocks of four was performed by using a specific software developed by GlaxoSmithKline (C4 Study Design Pack). Each centre was considered as one stratum. Randomized numbers were generated and assigned to participants, which were subsequently allocated to one study group, PRGF or hyaluronic... | PMC9850713 | |
Outcomes | INFILTRATION | According to the original protocol, participants were expected to be assessed 1, 2, and 6 months after the last treatment infiltration for the following outcomes: | PMC9850713 | |
Primary efficacy outcome | pain | The prespecified primary efficacy outcome was a clinically significant improvement in pain, measured as the percentage of patients with a decrease >40% in the score in the WOMAC pain subscale at the final visit with respect to baseline. This outcome was not presented in the published article but only in the unpublished... | PMC9850713 | |
Safety outcomes | ADVERSE EVENTS, ADVERSE EVENT, COMPLICATIONS | A record of complications and/or adverse events with imputation scale was performed. In accordance with the protocol, any sort of circumstances considered by researchers as an adverse event was to be recorded in detail in the booklet, including surgical or postsurgical complications. Non-severe adverse events or those ... | PMC9850713 | |
Statistical analysis | SECONDARY | With regard to the statistical analysis, RIAT investigators adhere to the original protocol procedures linked only to primary and secondary prespecified outcomes. A database was created to register and extract data from every endpoint described in the study protocol, including a statistical analysis when needed [Effica... | PMC9850713 | |
Discussion | PMC9850713 | |||
Main findings and contrast with original published article | knee osteoarthritis, pain | ADVERSE EVENTS, SECONDARY, KNEE OSTEOARTHRITIS | Our RIAT appraisal of Study PRGF underlined that no substantial differences in pain relief and other efficacy estimates were proved when adult participants with knee osteoarthritis were treated with plasma rich in growth factors or hyaluronic acid. As far as safety is concerned, there is no sound evidence about a diffe... | PMC9850713 |
Agreements and disagreements with other studies | Beyond the clinical trial carried out by Sánchez et al. [When studies are examined individually, there are important and repeated weaknesses: no randomization [ | PMC9850713 | ||
RIAT procedures | osteoarthritis | OSTEOARTHRITIS, OSTEOARTHRITIS | Compared to previous exercises, basically represented by the Study 329 [Following the RIAT principles, the study authors were offered from the beginning the possibility to correct themselves all detected inaccuracies. A call to action was publicly issued and sent to the study authors [The Osteoarthritis Research Societ... | PMC9850713 |
Strengths and limitations | Study PRGF was a randomized controlled trial with a modest sample size, although larger than most studies in its field [Beyond the specific characteristics of the trial, evidence of several protocol violations has been proved over the RIAT process, clearly undermining the results showed by the original journal publicat... | PMC9850713 | ||
Conclusions | knee osteoarthritis | ADVERSE EVENTS, KNEE OSTEOARTHRITIS | In contrast to the original published article by Sánchez and colleagues, our analysis of Study PRGF (originally coded as BTI-01-EC/07/ART) found no statistically significant differences between plasma rich in growth factors and hyaluronic acid in adults with knee osteoarthritis on any of the prespecified outcomes, incl... | PMC9850713 |
Acknowledgements | The authors would like to thank the RIAT Support Center ( | PMC9850713 | ||
Authors’ contributions | Conception of the work, acquisition of data and database creation: LCS. Database quality assessment and content review: JE, LL and MGV. Data analysis and interpretation: all authors. Drafting the work and revising it critically for important intellectual content, final approval of the version to be published: all autho... | PMC9850713 | ||
Funding | No specific funding has been received for this work. | PMC9850713 | ||
Availability of data and materials | All data for which the RIAT authors are directly responsible are included in this published article and its supplementary information files. This RIAT project has used third-party data to generate part of the results presented in the study, which cannot be made openly available. In agreement with the | PMC9850713 | ||
Declarations | PMC9850713 | |||
Ethics approval and consent to participate | The original version of this restored trial was approved by the Ethics Committee of the Basque Country, Spain, on 19 December 2007 (BTI-01-EC/07/ART). | PMC9850713 | ||
Consent for publication | According to the original publication of this restored trial, all patients provided written consent before entry into the study. | PMC9850713 | ||
Competing interests | The RIAT authors declare that they have no competing interests. | PMC9850713 | ||
References | PMC9850713 | |||
Background | RECRUITMENT | Global workforce challenges faced by health care providers are linked to low levels of job satisfaction, recruitment, retention, and well-being, with detrimental impacts on patient care outcomes. Resilience-building programs can provide support for staff who endure highly stressful environments, enhance resilience, and... | PMC9975925 | |
Objective | We aimed to examine participants’ engagement with a newly developed Resilience Enhancement Online Training for Nurses (REsOluTioN), explore its acceptability, and compare levels of resilience and psychological well-being in nurses who completed REsOluTioN with those who did not. | PMC9975925 | ||
Methods | MAY | We carried out a pilot randomized trial (1:1), conducted at a single site (mental health and community trust in South England) between August 2021 and May 2022. Local research ethics approvals were obtained. Nurses were invited to participate and were randomly assigned to a waitlist group or REsOluTioN group. Training ... | PMC9975925 | |
Results | Of 108 participants recruited, 93 completed the study. Participants’ mean age was 44 (SD 10.85) years. Most participants were female (n=95, 88.8%), White (n=95, 88.8%), and worked in community settings (n=91, 85.0%). Sixteen facilitated and 150 mentoring sessions took place. Most REsOluTioN program participants reporte... | PMC9975925 | ||
Conclusions | The REsOluTioN program was acceptable, engaging, perceived as useful, and nurses were keen for it to be implemented to optimize resilience, psychological health, communication, and workplace environments. The study has evidenced that it is acceptable to implement web-based resilience programs with similar design featur... | PMC9975925 | ||
Trial Registration | ClinicalTrials.gov NCT05074563; https://clinicaltrials.gov/ct2/show/NCT05074563 | PMC9975925 | ||
International Registered Report Identifier (IRRID) | RR2-10.2196/37015 | PMC9975925 | ||
Introduction | PMC9975925 | |||
Overview | RECRUITMENT | The ongoing global workforce challenges facing health care providers are well documented and are linked to low levels of job satisfaction, recruitment, retention, and staff well-being, with detrimental impacts on patient care outcomes [The development of evidence-based strategies to improve the psychological well-being... | PMC9975925 | |
Study Aim | The aim of this paper is to report on the implementation and evaluation of the REsOluTioN pilot RCT. Specific study objectives were to (1) explore participants’ engagement with the REsOluTioN trial, assessed by the number of nurses recruited to it; (2) explore the acceptability of the REsOluTioN program, assessed by pa... | PMC9975925 | ||
Methods | PMC9975925 | |||
Trial Design and Setting | The study was a 1:1 two-armed pilot randomized trial. It was conducted in a mental health and community National Health Service (NHS) trust in the South of England. | PMC9975925 | ||
Ethical Considerations | The Oxford Brookes University Faculty Research Ethics Committee (F.20.01.12.1, dated August 22, 2021) reviewed and approved the trial protocol. Other necessary local research and development office approvals were obtained from the Oxford Health NHS Foundation Trust Research and Development Department (21/HRA/1418). The... | PMC9975925 | ||
Recruitment | We invited nonagency nurses of different levels of seniority, working across a wide range of clinical settings from the participating NHS trust to participate. We used posters on the participating trust’s website, social media platforms, and meetings with nursing staff, research delivery teams, and trust communications... | PMC9975925 | ||
The REsOluTioN Program | The REsOluTioN program was hosted on the Totara learning management system (version 12), via the Learning and Development information technology team at the participating trust. The web-based training was conducted over 4 weeks and covered weekly modules on (1) building hardiness and maintaining a positive outlook, (2)... | PMC9975925 | ||
Waitlist Control | Nurses who were randomized to the control arm were allocated to a waitlist for 6 weeks. After 6 weeks, participants from both arms were asked to complete a poststudy survey ( | PMC9975925 | ||
Outcomes | The following outcome data were collected: (1) | PMC9975925 | ||
Data Management | All data were deidentified using study codes and stored in password-protected Excel (Microsoft Corp) spreadsheets that were accessed by authorized team members only. We followed the university’s policies and General Data Protection Regulation requirements for data storage. | PMC9975925 | ||
Sample Size | The limitations of the pilot study design, as well as finite resource availability, determined our sample size. The study objective was to afford a preliminary comparison of training outcomes, and due to funding constraints and the pressures imposed by COVID-19, we aimed to recruit between 60 and 100 participants; this... | PMC9975925 | ||
Randomization and Blinding | An independent team member who was not involved in the conduct of the trial, delivery of the REsOluTioN program, or data analysis implemented the randomization and allocation. For randomization, we used a computer-generated random number sequence. For allocation concealment, we used sequentially numbered opaque-sealed ... | PMC9975925 | ||
Statistical Methods | Participants’ demographic characteristics and acceptability outcomes (completers or noncompleters) were descriptively analyzed. Depending on the normality of the data, resilience and psychological well-being measures were presented as means (SD) or medians (IQR). Intention-to-treat analysis was carried out to examine o... | PMC9975925 | ||
Results | PMC9975925 | |||
Overview | A CONSORT diagram detailing the flow of participants through the pilot trial is presented in Consolidated Standards of Reporting Trials (CONSORT) flow diagram depicting flow of participants through the pilot trial. | PMC9975925 | ||
Participant Engagement and Retention | MAY | Between August 2021 and May 2022, a total of 134 nurses expressed an interest in participating in the study. Of 134, a total of 108 completed the web-based consent process and prestudy survey. One participant was excluded on the basis of eligibility as he/she was a nursing student rather than an employed member of staf... | PMC9975925 | |
Acceptability of the REsOluTioN Program | RECRUITMENT | Participants were allocated to waitlist control and REsOluTioN groups in 4 consecutive cohorts during the recruitment period. Cohort 1 had 14 people in the waitlist control and 6 in the REsOluTioN group, cohort 2 had 2 and 4, cohort 3 had 13 and 11, and cohort 4 had 22 and 26 participants, respectively. A total of 150 ... | PMC9975925 | |
Resilience and Psychological Well-being | Mean resilience and psychological well-being scores at baseline and 6 weeks for both groups are presented in Two-way mixed ANOVAs revealed no statistically significant differences between groups and time (baseline and 6 weeks) on resilience scores ( | PMC9975925 | ||
Discussion | PMC9975925 | |||
Principal Findings | RECRUITMENT | Our findings have shown that nurse participants engaged with REsOluTioN program, as evidenced by the high recruitment rate to the pilot study. The training was acceptable to nurses working in frontline clinical settings; this is demonstrated by the large number of participants who enrolled in and completed the study. W... | PMC9975925 | |
Comparison With Prior Work | Our findings have highlighted the potential need for resilience-enhancement programs for nurses working in highly stressful working conditions. This pilot trial was carried out across an NHS trust in South England during the height of the COVID-19 pandemic, when pressures on health care staff were extremely high, with ... | PMC9975925 | ||
Strengths and Limitations of the Study | RECRUITMENT | To our knowledge, REsOluTioN was the first web-based training piloted on nurses working during the COVID-19 pandemic and has highlighted many benefits of providing such a resource to nurses working under highly pressurized conditions. In addition, the engagement and acceptability outcomes have been achieved as indicate... | PMC9975925 | |
Conclusions | SB\ZA\101010662\633134 | This pilot RCT has identified the importance of, and need for, tailored resilience-enhancement programs for nurses, who are facing unprecedented workforce pressures and may benefit from additional forms of structured support. The components of the REsOluTioN program were well received, with specific emphasis placed on ... | PMC9975925 | |
Abbreviations | Consolidated Standards of Reporting TrialsNational Health Servicerandomized controlled trialResilience Enhancement Online Training for Nurses | PMC9975925 | ||
Data Availability | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC9975925 | ||
Abstract | PMC10109527 | |||
Objective | sleep behavior disorder, synucleinopathy, RBD, Prodromal | SYNUCLEINOPATHY | Rapid eye movement (REM) sleep behavior disorder (RBD) is widely considered a prodromal synucleinopathy, as most with RBD develop overt synucleinopathy within ~10 years. Accordingly, RBD offers an opportunity to test potential treatments at the earliest stages of synucleinopathy. The North American Prodromal Synucleino... | PMC10109527 |
Methods | narcolepsy, dementia, RBD, cognitive, motor, sensory, and autonomic function | MULTIPLE SYSTEM ATROPHY, PARKINSON'S DISEASE, NARCOLEPSY | Participants ≥18 years of age with overnight polysomnogram‐confirmed RBD without Parkinson's disease, dementia, multiple system atrophy, or narcolepsy were enrolled from nine sites across North America (8/2018 to 4/2021). Data collection included family/personal history of RBD and standardized assessments of cognitive,... | PMC10109527 |
Results | Outcomes are primarily reported based on sex (361 total: | PMC10109527 | ||
Interpretation | neurological abnormalities, RBD, cognitive, motor, sensory, and autonomic function | These RBD participants, assessed with extensive history, demographic, cognitive, motor, sensory, and autonomic function demonstrated a lack of sex differences and high frequency of concomitant neurological abnormalities. These participants will be valuable for future longitudinal study and neuroprotective clinical tria... | PMC10109527 | |
Introduction | MSA, DLB, sleep behavior disorder, Parkinson's disease, neurodegenerative diseases, synucleinopathies, PD, RBD, Prodromal, muscle atonia | DISORDER, PARKINSON'S DISEASE, NEURODEGENERATIVE DISEASES, DREAM ENACTMENT BEHAVIOR, SYNUCLEINOPATHY, DEMENTIA WITH LEWY BODIES, MULTIPLE SYSTEM ATROPHY, PATHOLOGY, EYE, STAGGERING | The North American Prodromal Synucleinopathy (NAPS) Consortium for Rapid Eye Movement (REM) sleep behavior disorder (RBD) was established to facilitate neuroprotective clinical trials for neurodegenerative diseases characterized by synuclein pathology. Such “synucleinopathies,” including Parkinson's disease (PD), demen... | PMC10109527 |
Materials and methods | PMC10109527 | |||
Overview | cognitive, motor, autonomic, or sensory domains, neurodegenerative | MAY | A complete methodological description of the NAPS Consortium protocol is published in a separate overview paper (Ju et al. Pending). Briefly, participants >18 years of age with polysomnogram‐confirmed RBD by ICSD‐3 criteriaData collection procedures and practices were rigorously standardized across sites, which include... | PMC10109527 |
RBDSS, obstructive or central) | SLEEP APNEA, RESTLESS LEGS SYNDROME | A NAPS‐specific structured interview queried for RBD symptoms, frequency, severity, treatments, and possible temporal relationship with any antidepressant or other medications. Diagnoses of sleep apnea (obstructive or central), restless legs syndrome, and periodic limb movement were determined during the clinician's st... | PMC10109527 | |
Other health history and questionnaires | ALZHEIMER | Demographic information and health history (including comprehensive family history) were obtained via structured interview and forms, including those from the Uniform Data Set version 3 (UDS3), from the National Alzheimer Coordinating Center ( | PMC10109527 | |
Neurological test battery | B‐SIT, Impaired orthostatic tolerance, orthostatic intolerance, Hg decrease, orthostatic blood pressure | Participants underwent a broad neurological test battery including objective tests of cognitive, motor, autonomic, and sensory (color vision and smell) function. Cognitive assessments included the psychometric battery from the UDS3 standard and LBD modulesMotor function was assessed via the Timed Up and Go (TUG),Autono... | PMC10109527 | |
Statistical analyses | Anxiety, RBDSS, loss of consciousness, Parkinson's Disease Autonomic Function, stress disorder, Parkinson's Disease Rating Scale, Movement Disorder, RBD, arrhythmias/bundle branch block, SCOPA | MOVEMENT DISORDER, OTHER CARDIOVASCULAR DISEASE, PARKINSON'S DISEASE | Statistical analyses were performed with SPSS and GraphPad Prism v9, with alpha at 0.05. Data are presented as mean, standard deviation, number, and percentage of the whole. Data for the whole group (Tables Demographic characteristics.Data are presented as mean ± standard deviation, or raw frequency count with percent ... | PMC10109527 |
Results | PMC10109527 | |||
Demographics | The participant cohort ( | PMC10109527 | ||
neurodegenerative signs, RBD | NEURODEGENERATION | The overall cohort reported mean RBD symptom onset at age 51.1 ± 16.3 (Table With regard to sex differences, RBD symptom onset occurred ~3 years earlier in women than men, a difference that was not statistically significant (48.9 ± 21.0 vs. 51.6 ± 18.1 years of age; Antidepressant usage within the overall population wa... | PMC10109527 | |
Health history | anxiety, traumatic brain injury, delusions, hallucinations, Urinary and bowel incontinence, TBI, sexual dysfunction, PTSD, orthostatic hypotension, RBD, depression, apathy/indifference | ORTHOSTATIC HYPOTENSION | The most commonly reported health problems in the cohort (Table Autonomic function, as assessed by SCOPA‐AUT, averaged 13.5 ± 7.8 in the overall cohort, not significantly different between men and women. Urinary and bowel incontinence, as well as orthostatic hypotension were not different between men and women. Men rep... | PMC10109527 |
Neurological test battery results | orthostatic tolerance, Orthostatic hypotension | ORTHOSTATIC HYPOTENSION | The cognitive battery revealed relatively normal mean scores in the overall cohort, with women having better scores in the MoCA (27.1 ± 4.5 vs. men 26.0 ± 5.3; Distribution of scores in primary domains of function. The distribution of individual scores (open circles) with the mean value indicated via the shaded bar and... | PMC10109527 |
Family history | MSA, DLB, sleep disorders, Systems Atrophy, Parkinson's Disease, neurologic and sleep disorders, PD, neurological diseases, Alzheimer's Disease, Dementia, RBD, AD | DEMENTIA WITH LEWY BODIES, NEUROLOGICAL DISEASE, PARKINSON'S DISEASE, ALZHEIMER'S DISEASE | Participants in this study provided extensive family history information (Fig. Genealogy of known RBD and related neurologic and sleep disorders. Participant (shaded center box) with offspring, sibling, and maternal (m.) and paternal (p.) family members. Non‐shaded circles indicate female sex and non‐shaded squares ind... | PMC10109527 |
Discussion | atonia, idiopathic RBD, neurological impairment, neurological abnormalities, RBD | DISEASE | We report characteristics of the initial NAPS Consortium cohort as measured through a standardized, comprehensive clinical assessment. Consistent with previous literature, we found a male preponderance for RBD (~80%),Even across 9 sites, there was a high male:female ratio in our RBD cohort, yet a striking lack of diffe... | PMC10109527 |
Author Contributions | DEH | Conception and design of the study. JEE, MML, ATK, RBP, AP, JFG, EKSL, LKF, JAF, DLB, DEH, AYA, MJH, CHS, JM, SRC, AV, EHD, MGM, DRS, JKLI, BFB, YSJ. Acquisition and analysis of data. JEE, MML, ATK, RBP, AP, JFG, EKSL, LKF, JAF, DLB, DEH, AYA, MJH, CHS, JM, SRC, AV, EHD, MGM, DRS, JKLI, BFB, YSJ. Drafting a significant... | PMC10109527 | |
Conflict of Interest | Respicardia, NINDS, Dementia | SCHENCK, LEWY BODY DEMENTIA, BRAIN, FOX, LITTLE, HEART, ALZHEIMER |
Dr. Elliott has received support from the Department of Veteran Affairs, NIH (NHLBI, NIA, NCCIH), Oregon Medical Research Foundation, Portland VA Research Foundation, Eugene & Clarissa Evonuk Foundation in Environmental Physiology, and American Heart Association.Dr. Lim has received support from Department of Veteran ... | PMC10109527 |
Acknowledgements | The authors would like to express their sincere appreciation and gratitude for the participation of our research subjects, and to the entire NAPS consortium. Financial support from NIH grants R34 AG056639, U19 AG071754, P50 AG016574, P30 AG62677; VA RRD 1K2 RX002947; and Canadian support via Research Chair in Cognitive... | PMC10109527 | ||
References | PMC10109527 | |||
Subject terms | tumors | RESIDUAL DISEASE, TUMORS, HER2-POSITIVE BREAST CANCER | The identification of prognostic markers in patients receiving neoadjuvant therapy is crucial for treatment optimization in HER2-positive breast cancer, with the immune microenvironment being a key factor. Here, we investigate the complexity of B and T cell receptor (BCR and TCR) repertoires in the context of two phase... | PMC10624889 |
Introduction | tumor, breast cancer | TUMOR, CYTOTOXICITY, HER2-POSITIVE BREAST CANCER, BREAST CANCER | Neoadjuvant treatment escalation approaches with dual anti-human epidermal growth factor receptor 2 (HER2) blockade have been proven effective in early-stage HER2-positive breast cancer, leading to an increase in pathological complete response (pCR) ratesHER2-positive breast cancer is considered an immunogenic tumor, a... | PMC10624889 |
Results | PMC10624889 | |||
BCR and TCR repertoires in the NeoALTTO and CALGB 40601 trials | tumor | TUMOR, HER2-POSITIVE BREAST CANCER | Aiming at investigating the complexity of the immune response in HER2-positive breast cancer, we explored the diversity of BCR and TCR repertoires in pre-treatment baseline tumor samples. The MiXCR toolIn NeoALTTO, all samples had at least one read mapping to BCR, while one sample did not have any read mapping to TCR. ... | PMC10624889 |
BCR and TCR repertoires are heterogeneous according to hormone receptor status and PAM50 subtypes, and correlate with TIL levels | We next explored the association of BCR and TCR repertoires with hormone receptor status, PAM50 subtypes, and TIL levels, scored as % of the intratumoral stroma area following the International TILs Working Group guidelinesAs shown in Fig. | PMC10624889 |
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