Clinical trial · Interventional
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
NCT04002986CI-TRIAL-00068218completedN/AClinicalTrials.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)
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.
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 |
|---|---|---|---|
| Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic Testing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women at intermediate/high risk of breast cancer
- description
- Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing
- interventionNames
- Genetic: Genetic Testing
Primary outcomes (2)
- measure
- Genetic mutations
- timeFrame
- One year
- description
- Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
- measure
- Study Participants
- timeFrame
- One year
- description
- Number of subjects who decide to undergo genetic panel testing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Women participating in IRB:18-010601 * Aged 35 and over with a negative routine mammogram within 3 months. * Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8). * Have an active email address for survey completion Exclusion Criteria: * Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601) * Known genetic cancer syndrome with test results available for review in Mayo EMR * Known breast cancer * Unable to understand or sign informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.