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Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02310594
Collaborator
(none)
139
Enrollment
1
Location
145.1
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research trial studies the effect of radiation therapy on tumor immunity. Standard radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this response is often ineffective in shrinking tumor tissue. Collecting samples of blood from patients before, during, and after radiation therapy to study in the laboratory may help doctors learn more about the effects of radiation therapy on anti-tumor response.

Condition or Disease Intervention/Treatment Phase
  • Other: cytology specimen collection procedure
  • Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:
  1. To assess the effect of radiation therapy on tumor immunity.
OUTLINE:

Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

Study Design

Study Type:
Observational
Actual Enrollment :
139 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Radiation Therapy on Tumor Immunity
Actual Study Start Date :
Jul 8, 2010
Actual Primary Completion Date :
Aug 9, 2022
Actual Study Completion Date :
Aug 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Ancillary-Correlative (blood banking)

Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

Other: cytology specimen collection procedure
Undergo blood sample collection
Other Names:
  • cytologic sampling

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Outcome measures include changes in tumor-specific immune responses and general immune signature in patients undergoing Radiation Treatment. Reportable endpoints are absolute values of and changes in innate & adaptive immune cells and serum markers. [The time line of interest covers a baseline, pre-treatment sample as well as mid-treatment and a post-treatment, follow-up sample at 3 months.]

    Eligibility Criteria

    Criteria

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

    • Signed and dated Institutional Review Board (IRB)-approved Informed Consent form for the study

    • Received an explanation of the study, including satisfactory answers to all questions related to the proposed research

    • Is undergoing physician directed radiation treatment

    Exclusion Criteria:
    • The potential Subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Michael Steinberg, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02310594
    Other Study ID Numbers:
    • 10-001588
    • NCI-2014-02231
    • 10-001588-CR-00004
    • Steinberg122308
    • 09-01-010
    First Posted:
    Dec 8, 2014
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2022