Dataset Information

Clinical trials optimizing investigator and self-collection of buccal cells for RNA yield.

ABSTRACT:

Objective

Buccal cells are an ideal surrogate tissue for studying biologic effects of carcinogens or drugs, however inherent fragility and salivary RNAses limit RNA yield. We conducted healthy volunteer trials to optimize collection conditions.

Methods

We conducted: (a) a single-arm crossover study evaluating four test conditions on RNA yield by buccal cytobrush; (b) a single-arm prospective study evaluating RNA yield by investigator vs self-collection.

Results

Antecedent toothbrushing, time of day, and number of cytobrush strokes did not significantly impact RNA yield. RNA yield was doubled by using 2 vs 1 cytobrush per buccal surface (P = .0054). Self-collection of buccal cells for RNA was feasible; 36 of 50 (72%) samples passed quality control.

Conclusion

RNA yield was doubled by using two cytobrushes per buccal surface. Healthy volunteers can self-collect sufficient buccal RNA for gene expression studies. Techniques from these pragmatic trials could enhance availability of a limited tissue for serial biomarker measurements.

Level of evidence

1b-Prognosis Study (Individual prospective cohort study).

SUBMITTER: Geiger JL

PROVIDER: S-EPMC7883625 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical trials optimizing investigator and self-collection of buccal cells for RNA yield.

Geiger Jessica L JL Cedars Elizabeth D ED Zang Yan Y Normolle Daniel P DP Li Hua H Grandis Jennifer R JR Centuori Sara S Johnson Daniel E DE Bauman Julie E JE

Laryngoscope investigative otolaryngology 20210118 1

<h4>Objective</h4>Buccal cells are an ideal surrogate tissue for studying biologic effects of carcinogens or drugs, however inherent fragility and salivary RNAses limit RNA yield. We conducted healthy volunteer trials to optimize collection conditions.<h4>Methods</h4>We conducted: (a) a single-arm crossover study evaluating four test conditions on RNA yield by buccal cytobrush; (b) a single-arm prospective study evaluating RNA yield by investigator vs self-collection.<h4>Results</h4>Antecedent t ...[more]

PMID: 33614939

Similar Datasets

Project description:BackgroundHealthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines.MethodsWe examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial's impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions.ResultsFor 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs.ConclusionAn encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

Project description:BackgroundA 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research.ObjectivesThe overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR).MethodsWe used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature.ResultsA total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation.ConclusionOur digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.

Dataset Information

Clinical trials optimizing investigator and self-collection of buccal cells for RNA yield.

Objective

Methods

Results

Conclusion

Level of evidence

Publications

Clinical trials optimizing investigator and self-collection of buccal cells for RNA yield.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets