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NCT03605004 · ClinicalTrials.gov registry record
Adult Patients With Undiagnosed Conditions and Their Responses to Clinically Uncertain Results From Exome Sequencing
A clinical trial of Undiagnosed Disease, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- 26
- Enrollment target
- 2
- Study locations
NCT03605004 is a study of Undiagnosed Disease that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 26 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT03605004, a study of Undiagnosed Disease, has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: People with conditions that are unknown or hard to diagnose may be helped by a genetic technique. It is called exome sequencing. It helps diagnose disease by unlocking all the data in a person s genetic code. But the results from it are often unclear. Uncertain results can pose problems for doctors and patients. Researchers want to learn more about how people respond when they get uncertain results. Objective: To study the psychological and behavioral effects of getting uncertain results from exome sequencing. Eligibility: Adults who have: Had a diagnostic odyssey for at least 6 months. An example is having clinical symptoms but no diagnosis. And had exome sequencing to try to reach a diagnosis. Design: Participants will choose a date and time for their interview. They will sign a form to give consent and authorization. Participants will fill out 2 forms. One is the Intolerance of Uncertainty Short Form Scale. The other is the Perceptions of Uncertainties in Genome Sequencing Scale. Both scales ask about what it is like to get clinically uncertain results from exome sequencing. They focus on coping and other behavioral responses. Participants will have a phone interview. It will last for 45-60 minutes. It will be recorded and transcribed. At the start of the call, the researcher will review the consent form with the participant. Participants will give data such as race, education, income, and how long they have been looking for a diagnosis. Participants will read their responses to the 2 scales during the interview.
Conditions Studied
Study Locations (2)
Maryland
- Johns Hopkins School of Public Health - Baltimore
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2020-05-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03605004
The ClinicalTrials.gov registry entry for NCT03605004 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Undiagnosed Disease appearing as the primary indexed condition, and to 0 interventions.
NCT03605004 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03605004 about?
NCT03605004 is a clinical study titled "Adult Patients With Undiagnosed Conditions and Their Responses to Clinically Uncertain Results From Exome Sequencing". Background: People with conditions that are unknown or hard to diagnose may be helped by a genetic technique. It is called exome sequencing. It helps diagnose disease by unlocking all the data in a person s genetic code. But the results from it are often unclear. Uncertain results can pose problems...
What is the current status of trial NCT03605004?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2018-08-13. Estimated completion is 2020-05-07.
What conditions does trial NCT03605004 study?
This clinical trial studies the following conditions: Undiagnosed Disease.
Who is sponsoring clinical trial NCT03605004?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03605004 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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