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

Malignant Neoplasm Clinical Trial

Official title:

The Effect of Radiation Therapy on Tumor Immunity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02310594
• Other study ID #: 10-001588
• Secondary ID: NCI-2014-0223110
• Status: Terminated
• Start date: July 8, 2010
• Est. completion date: August 9, 2022

Study information

• Verified date: January 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• cytology specimen collection procedure
Undergo blood sample collection
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.