Clinical trial · Observational
Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing
NCT01992471CI-TRIAL-00030681completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Other | — | UNRESOLVED |
| Follow-up assessments (6 and 12 months) | Behavioral | — | UNRESOLVED |
| Post-test counseling, and post-test assessment | Behavioral | — | UNRESOLVED |
| Pre-test Assessment | Behavioral | — | UNRESOLVED |
| Pre test Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- history of breast cancer who have undergone BRCA1/2 testing
- description
- This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.
- interventionNames
- Behavioral: Pre-test Assessment
- Behavioral: Pre test Counseling
- Other: Blood draw
- Behavioral: Post-test counseling, and post-test assessment
- Behavioral: Follow-up assessments (6 and 12 months)
Primary outcomes (1)
- measure
- women's preferences with respect to the type of information they would like to receive from multiplex testing
- timeFrame
- 2 years
- description
- Proportions of subjects declaring a pre-test preference to receive 1) all available information, 2) all information related to breast cancer predisposition (whether or not clinical utility is established), 3) all information of established clinical utility (whether related to breast cancer risk or not), 4) only a subset of high-penetrance information (masking certain results), 5) no information.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female age 18 or older * Personal history of breast cancer AND one of the following: * Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following: * Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. The "limited family history" can occur on either the maternal or paternal side of the family.) * 1 or more first-/second-degree relatives with invasive BC at/before 50 * 1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age) * 1 or more first- or second-degree relatives with male breast cancer * 2 or more first- or second-degree relatives with pancreas cancer * Invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer. * Full sequence BRCA1 and BRCA2 testing completed with no deleterious mutation identified. Exclusion Criteria: * Unable to provide informed consent for testing * Unable to complete English language questionnaire
References
Publications (0)
Data not yet available
No reference posted for this study.