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Clinical Trial Summary

This study assesses changes to the immune cells following hypofractionated radiation-induced DNA damage in breast cancer patients. Radiation therapy may cause immune cells to enter tumors and target cancer cells. The goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy). SECONDARY OBJECTIVE: I. To estimate the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline. II. To examine cancer cell intrinsic immune signaling following radiotherapy. EXPLORATORY OBJECTIVE: I. To examine the association between DNA damage and micronuclei formation. II. To examine the association between DNA damage and immune infiltration. III. To examine the association between micronuclei formation and immune infiltration. OUTLINE: Patients undergo RT on day 1. Patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05406232
Study type Observational
Source M.D. Anderson Cancer Center
Contact Simona F Shaitelman, MD
Phone (713) 563-8491
Email sfshaitelman@mdanderson.org
Status Recruiting
Phase
Start date September 15, 2023
Completion date December 31, 2026

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