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NCT01927770 · ClinicalTrials.gov registry record
A Study of Consent Forms for Whole Exome and Whole Genome Sequencing
A clinical trial, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- 212
- Enrollment target
NCT01927770: Completed study, sponsored by National Human Genome Research Institute (NHGRI).
NCT01927770 is a clinical trial that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 212 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01927770 has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- 212 participants
- Enrollment target
Study Summary
Background: The purpose of this study is to investigate the process of consenting participants to whole exome/genome sequencing and its outcomes. It is unknown how best to consent people to this new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a companion to other NIH studies that involve genomic sequencing. Participants must be enrolled in a parent NIH study that is collaborating on this consent study to be eligible. Currently this involves only one NIH study. Objectives: \- To learn the best way to help participants understand sequencing, so they can decide whether to join studies that use it. Eligibility: * Adults at least 18 years old who are enrolled in a National Institutes of Health (NIH) study that uses WES/WGS. * Adults at least 18 years old whose children are enrolled in an NIH study that uses WES/WGS. Design: * Participants will take part in the study either in person or over the phone. * Participants will review two sequencing consent forms with a genetic counselor. * Before and after meeting with the counselor, participants will answer several questions about sequencing. Each questionnaire will take about 15 minutes. * Six weeks later, participants will answer questions about sequencing. This will take about 15 minutes.
Primary Outcome
To contrast the efficacy of an evidence-based streamlined consent model (based upon the integration of an expert opinion model and laypersons responses using a mental- models approach) to a standard NIH consent in consenting adult and parent participants to undergo WES/WGS within NIH Intramural studies.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2013-12-16 |
| Est. Completion | 2021-11-08 |
What the finished NCT01927770 record still lists
NCT01927770 is an observational study that tracks outcomes without assigning an intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01927770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01927770 about?
NCT01927770 is a clinical study titled "A Study of Consent Forms for Whole Exome and Whole Genome Sequencing". Background: The purpose of this study is to investigate the process of consenting participants to whole exome/genome sequencing and its outcomes. It is unknown how best to consent people to this new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a companion to o...
What is the current status of trial NCT01927770?
This trial is currently completed. The enrollment target is 212 participants. The study started on 2013-12-16. Estimated completion is 2021-11-08.
Who is sponsoring clinical trial NCT01927770?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
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