Pilot study of the effect of weight loss on breast tissue and blood biomarkers in women at increased risk for breast cancer

Investigating the Effects of Weight Loss from Bariatric Surgery on Breast Cancer Biomarkers and Breast Density

Recruiting
18 years - 75 years
Female
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to see the effects that weight loss after bariatric surgery might have on certain breast cancer biomarkers and breast density.

Detailed description of study

The purpose of this study is to investigate the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer tissue and blood as well as on imaging in women at elevated risk for breast cancer.

Participants will be compensated for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: breast cancer,obesity,weight loss,cancer,oncology
  • Age: 18 years - 75 years
  • Gender: Female

Inclusion Criteria
Must be at elevated risk for breast cancer
Must be willing to provide a core tissue biopsy at baseline and with repeat tissue collection after 2 weeks and 12 months post-bariatric surgery
ECOG Performance Status of 0 - 1 within 28 days of registration
Patients must be planning to undergo primary bariatric surgery (no revisions)
Exclusion Criteria
No history of any malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > or = 5 years
No concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1, or their receptors
Weight cannon exceed 500 lbs. at the time of imaging
Known allergy to gadolinium which us used for MRI contrast

Updated on 19 Feb 2024. Study ID: 1511957605 (IUSCC-0556)

This study investigates the effects of weight loss after bariatric surgery on breast cancer biomarkers and breast density. Biomarkers are substances in the body that can indicate a disease or condition, and breast density refers to the amount of fibrous or glandular tissue compared to fatty tissue in the breasts. The study focuses on women who are at an elevated risk for breast cancer.

Participants will undergo procedures including a core tissue biopsy, which involves taking a small sample of breast tissue for testing. This will happen at the start of the study, and again two weeks and twelve months after the surgery. Blood samples and imaging tests will also be conducted to observe changes in breast cancer risk factors.

  • Who can participate: Women who are at an elevated risk for breast cancer and are planning to undergo primary bariatric surgery can participate. Participants must be willing to provide tissue samples, meet specific health criteria, and have no known allergies or weight limitations that could affect the study.
  • Study details: Participants will provide tissue samples and undergo imaging tests. A placebo is not used in this study.

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