A Study of Consent Forms for Whole Exome and Whole Genome Sequencing
Public ClinicalTrials.gov record NCT01927770. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Trial of Consent Interventions for NIH Whole Exome and Whole Genome Sequencing Studies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01927770
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 212 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2013
- Primary completion
- Mar 6, 2016
- Completion
- Nov 7, 2021
- Last update posted
- Nov 9, 2021
2013 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01927770, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01927770 live on ClinicalTrials.gov.