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Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer

NCT02681120 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2021-10-14

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Biopsy

PROCEDURE

Blood draw

PROCEDURE

Mammogram

PROCEDURE

MRI

Sponsors & Collaborators

  • Tarah J Ballinger, MD

    lead OTHER

Principal Investigators

  • Tarah Ballinger, MD · Indiana University School of Medicine, Indiana University Simon Cancer Center

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-07
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02681120 on ClinicalTrials.gov