Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer
Public ClinicalTrials.gov record NCT02681120. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a pilot, non-randomized, single institution, observational study investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at elevated risk for breast cancer who are already planning to undergo bariatric surgery will be consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and approximately 1 year after bariatric surgery. In parallel we will also be assessing 40 normal breast tissue specimens as well as blood samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI, elevated risk control group for our study. The KTB samples will be matched for general risk of breast cancer (\>20%), age, race and menopausal status.
Study identification
- NCT ID
- NCT02681120
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 6, 2016
- Primary completion
- Jan 29, 2020
- Completion
- Jan 29, 2020
- Last update posted
- Oct 13, 2021
2016 – 2020
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University Health North Hospital | Carmel | Indiana | 46032 | — |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02681120, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02681120 live on ClinicalTrials.gov.