Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT05406232
- Status
- Recruiting
Conditions
- Breast Carcinoma
- Invasive Breast Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biopsy — PROCEDUREUndergo tumor punch biopsy
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Radiation Therapy — RADIATIONUndergo RT
Study Details
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.
Key Dates
- Start date
- Sep 15, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 36 participants (estimated)
Arms
- Arm: Observational (RT, biopsy)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.
Primary Outcome Measure
Percent change of CD8+ T cells [ Time Frame: Baseline up to day 8 ]
Central Contacts
- Simona F Shaitelman, MD(713) 563-8491
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Simona F. Shaitelman, MD (PRINCIPAL_INVESTIGATOR) |
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