Clinical trial · Observational
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
NCT00291096CI-TRIAL-00096865recruitingClinicalTrials.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 overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prediction of risk for developing breast cancer
- timeFrame
- ongoing
- description
- development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * women with at least 2 times the normal risk of developing breast cancer * between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative) * greater than six months from ingestion of antihormonal therapy * greater than 1 year from pregnancy, lactation, or chemotherapy * willing to have a mammogram within six months prior to RPFNA * willing to discontinue NSAIDS or herbal supplements * willing to have blood drawn Exclusion Criteria: * no metastatic malignancy of any kind * no breast implants or tram flap reconstructions * no radiation to both breasts * no women who have a current mammogram or clinical breast exam suspicious for cancer
References
Publications (0)
Data not yet available
No reference posted for this study.