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

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ClinicalTrials.gov Identifier: NCT02310594
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Malignant Neoplasm Other: cytology specimen collection procedure Other: laboratory biomarker analysis

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Radiation Therapy on Tumor Immunity
Actual Study Start Date : July 8, 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Group/Cohort 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 Name: cytologic sampling

Other: laboratory biomarker analysis
Correlative studies




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. [ Time Frame: 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult cancer patients undergoing physician directed radiation treatment.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310594


Locations
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United States, California
Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Michael L. Steinberg    310-794-1252    msteinberg@mednet.ucla.edu   
Principal Investigator: Michael L. Steinberg         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Steinberg Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02310594    
Other Study ID Numbers: 10-001588
NCI-2014-02231 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-001588-CR-00004 ( Other Identifier: Jonsson Comprehensive Cancer Center )
Steinberg122308
09-01-010 ( Other Identifier: Jonsson Comprehensive Cancer Center )
10-001588 ( Other Identifier: Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Neoplasms