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NCT02681120 · ClinicalTrials.gov registry record
Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer
A clinical trial, sponsored by Tarah J Ballinger, MD.
- Completed
- Registry status
- 3
- Enrollment target
NCT02681120: Completed study, sponsored by Tarah J Ballinger, MD.
NCT02681120 is a clinical trial that has completed, run by Tarah J Ballinger, MD. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02681120 has completed, sponsored by Tarah J Ballinger, MD.
- COMPLETED
- Registry status
- 3 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change
Interventions
- PROCEDURE Biopsy
- PROCEDURE Mammogram
- PROCEDURE MRI
- PROCEDURE Blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-10-07 |
| Est. Completion | 2020-01-30 |
What the finished NCT02681120 record still lists
NCT02681120 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Biopsy is the first listed.
NCT02681120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02681120 about?
NCT02681120 is a clinical study titled "Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer". 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...
What is the current status of trial NCT02681120?
This trial is currently completed. The enrollment target is 3 participants. The study started on 2016-10-07. Estimated completion is 2020-01-30.
What interventions are being tested in trial NCT02681120?
The interventions under investigation include: Biopsy (PROCEDURE), Mammogram (PROCEDURE), MRI (PROCEDURE), Blood draw (PROCEDURE).
Who is sponsoring clinical trial NCT02681120?
This trial is sponsored by Tarah J Ballinger, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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