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

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis

• Registration Number: NCT02310594
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

PRIMARY OBJECTIVES:

I. 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 Timeline

• Study Start: 2010-07-08
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Status Verified: 2022-01
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (blood banking)	cytology specimen collection procedure	Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.
Ancillary-Correlative (blood banking)	laboratory biomarker analysis	Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States