NCT04257045Completed
Factors Influencing Cascade Testing Among Women With Hereditary Gynecological Cancers and Their Relatives
Source: ClinicalTrials.gov · Last updated 12 Jul 2024
Brief summary (registry, in English)
This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 4 Feb 2020
- Start date
- 21 Aug 2019
- Primary completion date
- 9 Jul 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Endometrial cancer, Ovarian cancer
- NCT number
- NCT04257045
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From 21 Aug 2019 to the primary completion date, 9 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- STEP 1 (PROBANDS): No longer receives outpatient care at LBJ
- STEP 1 (PROBANDS): Has a negative genetic testing result, a result identifying only a variant of uncertain significance, or results and pedigree that cannot be confirmed in the electronic medical record
- STEP 1 (PROBANDS): Is unwilling or unable to provide informed consent
- STEP 1 (FIRST-DEGREE RELATIVE \[FDR\]): Unwilling or unable to provide informed consent
- STEP 2 (PROBANDS): No longer receives outpatient care at LBJ or MD Anderson
- STEP 2 (PROBANDS): Has a negative genetic testing result, a result identifying only a variant of uncertain significance, or results and pedigree that cannot be confirmed in the electronic medical record
- STEP 2 (PROBANDS): Unwilling or unable to provide informed consent
- STEP 2 (PROBANDS): Participated in step 1 interviews
- STEP 2 (FDR): Unwilling or unable to provide informed consent
- STEP 2 (FDR): Reports no knowledge of proband's genetic testing status
- STEP 2 (FDR): Participated in step 1 interviews
Who the study is looking for
- STEP 1 (PROBANDS): Speaks and/or reads English or Spanish
- STEP 1 (PROBANDS): Currently receiving diagnostic, treatment, or follow-up care in the outpatient gynecologic oncology and medical oncology clinics at LBJ
- STEP 1 (PROBANDS): Has completed genetic counseling, with pedigree available in the medical record (LBJ)
- STEP 1 (PROBANDS): Diagnosed with female-breast, ovarian, fallopian tube, primary peritoneal, endometrial cancer on or after January 1, 2014
- STEP 1 (PROBANDS): Has a confirmed deleterious or suspected deleterious (pathogenic) variant in a hereditary gynecologic or breast cancer predisposition gene (including BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, BRIP1, PALB2, RAD51C, RAD51D, STK11, DICER1, SMARCA4, ATM, CHEK2, PTEN, TP53, CDH1, BARD1)
- STEP 1 (FIRST-DEGREE RELATIVE \[FDR\]): Speaks and/or reads English or Spanish
- STEP 1 (FDR): Is a first-degree relative of proband (son, daughter, full-brother, full-sister, mother, father)
- STEP 1 (FDR): Is present with proband at time of recruitment, or can be contacted by telephone via a United States (U.S.) telephone number
- STEP 1 (FDR): Is aware of proband's genetic testing result/mutation status, per proband report
- STEP 2 (PROBANDS): Speaks or reads English or Spanish
- STEP 2 (PROBANDS): Currently receives diagnostic, treatment, or follow-up care for female-breast cancer in the outpatient medical oncology clinics at LBJ; or currently receives diagnostic, treatment, or follow-up care for ovarian, fallopian tube, primary peritoneal or endometrial cancer in the outpatient gynecologic oncology clinic at LBJ or the outpatient gynecologic oncology clinic at The University of Texas MD Anderson Cancer Center (MD Anderson)
- STEP 2 (PROBANDS): Diagnosed with eligible cancer on or after January 1, 2014
- STEP 2 (PROBANDS): Has completed genetic counseling, with a pedigree available in the medical record (LBJ) or internal clinical and research database (progeny at MD Anderson)
- STEP 2 (PROBANDS): Has a confirmed deleterious or suspected deleterious (pathogenic) variant in a hereditary gynecologic or breast cancer predisposition gene (including BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, BRIP1, PALB2, RAD51C, RAD51D, STK11, DICER1, SMARCA4, ATM, CHEK2, PTEN, TP53, CDH1, BARD1)
- STEP 2 (FDR): Speak and/or reads English or Spanish
- STEP 2 (FDR): First-degree relative of proband (son, daughter, full-brother, full-sister, mother, father)
- STEP 2 (FDR): Is present with proband at time of recruitment, or can be contacted by telephone via a U.S. telephone number
- STEP 2 (FDR): Is aware of proband's genetic testing result/mutation status, per proband report
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.