M D Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
Location contact
Simona F. Shaitelman, MD
CONTACT
Simona F. Shaitelman, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05406232
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Houston, Texas, 77030, United States
Location status: Recruiting
Simona F. Shaitelman, MD
CONTACT
Simona F. Shaitelman, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo tumor punch biopsy
Other names: BIOPSY_TYPE, Bx
Undergo blood sample collection
Other names: Biological Sample Collection, Biospecimen Collected
Undergo RT
Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Time frame: Baseline up to day 8
Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals.
Time frame: Baseline up to day 8
Will be estimated with corresponding two-sided 80% confidence intervals. Also, marker levels at each time point and unstandardized effect sizes (arithmetic differences from baseline) across time points will be estimated along with 2-sided 80% confidence intervals.
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02876107
Breast Carcinoma, Breast Diseases
Houston, Texas, United States
View Trial DetailsNCT05036083
Breast Carcinoma, Breast Diseases
Houston, Texas, United States
View Trial DetailsNCT04022772
Adenocarcinoma, Breast Carcinoma
Houston, Texas, United States
View Trial DetailsNCT07285044
Adenocarcinoma, Adnexal Diseases
Jacksonville, Florida, United States
View Trial Details