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NCT01646112
Uncertain Genetic Test Results for Lynch Syndrome
trial in HNPCC in 27 participants. Completed in 5 February 2016.
Quick facts
| Lead sponsor | National Human Genome Research Institute (NHGRI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 27 |
| Start date | 25 April 2012 |
| Estimated completion | 5 February 2016 |
| Sites | 1 location across United States |
Conditions studied
- HNPCC — all drugs for HNPCC →
Sponsor
National Human Genome Research Institute (NHGRI)
Who can join
Adults 18 to 100, any sex, with HNPCC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: * Individuals have varying tolerances for receiving ambiguous information. However, not much is known about how ambiguous genetic testing information is received. Also, not much is known about how at-risk individuals internalize and process these results. More information is needed about how this information affects a person s life. * Lynch Syndrome is a genetic condition that carries a high risk of colon cancer and other cancers. Individuals at risk for Lynch Syndrome can have genetic testing for it. The test may confirm a diagnosis and determine actions that can be taken. Results from genetic testing can also affect the perspectives of relatives who might also be affected. However, genetic testing can also produce variants of unknown significance (VUS). VUS are data that may not provide enough information to make decisions. Researchers want to study people who have received a VUS result for genetic testing for Lynch Syndrome. Objectives: \- To learn more about the impact and experience of receiving a VUS for Lynch Syndrome genetic testing. Eligibility: \- Individuals at least 18 years of age who have recently had a VUS result on a genetic test for Lynch Syndrome. Design: * Participants will be asked to answer demographic questions. They will also have a 45- to 60-minute phone interview. * During the phone interview, participants will be asked a series of questions about their diagnosis. They will be asked about how they received the result and how they felt right after receiving it. They will also discuss who they have spoken to about the result.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01646112
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for HNPCC
Currently open trials in the same condition.
- NCT06708429 — Lynch Syndrome X-Talk of Enteral Mucosa With Immune System · recruiting
Other National Human Genome Research Institute (NHGRI) trials
Trials by the same sponsor.
- NCT05657405 — Observational Study of Advanced Data Analytics in Genetic Conditions · recruiting
- NCT06948110 — Deciphering the Genetic Architecture of Autoimmune Diseases · recruiting
- NCT06664814 — An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomeruloscleros · Phase 2 · recruiting
- NCT06595940 — Genetic Analysis of Uncommon Disease Presentations in Non-US Populations · recruiting
- NCT06552754 — Cybersickness Prevention and Mitigation in Virtual Reality for Healthy Volunteers · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01646112 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Human Genome Research Institute (NHGRI)
- Last refreshed: 17 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01646112.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing