Clincosm LogoSign in Get a demo

Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05406232
Collaborator
(none)
12
Enrollment
1
Location
16
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy
  • Procedure: Biospecimen Collection
  • Radiation: Radiation Therapy

Detailed Description

PRIMARY OBJECTIVE:
  1. To estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (RT) relative to baseline (before radiotherapy).
SECONDARY OBJECTIVE:

  1. To estimate the degree of deoxyribonucleic acid (DNA) damage at approximately 3 and 7 days after radiotherapy compared to baseline.

  2. To examine cancer cell intrinsic immune signaling following radiotherapy.

EXPLORATORY OBJECTIVE:
  1. 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

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quantifying Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Biopsy
Undergo tumor punch biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

    • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

    • Radiation: Radiation Therapy
    Undergo RT
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To estimate the percent change in immune infiltration. [Baseline up to day 7]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients >= 18 years of age with biopsy proven invasive breast cancer

    • Breast cancer that appears to be superficially accessible to a tumor punch biopsy

    • Patients thought to derive clinical benefit from palliative RT to the breast/chestwall

    • In discussions with the medical oncologist, if clinically reasonable, systemic therapy will be held during RT

    Exclusion Criteria:

    • A history of prior radiation to the area requiring radiation for which the attending physician believes reirradiation could not be safely delivered

    • Pregnancy

    • Active usage of anticoagulant medications that are considered to pose an increased risk of tumor punch biopsies

    • Receipt of immunotherapy or chemotherapy 7 days prior to start of RT

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Simona F Shaitelman, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05406232
    Other Study ID Numbers:
    • 2021-0669
    • NCI-2021-09773
    • 2021-0669
    First Posted:
    Jun 6, 2022
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms

    Study Results

    No Results Posted as of Jun 6, 2022