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

NCT02310594 | Terminated

• 5 other identifiers: 10-001588NCI-2014-0223110-001588-CR-00004Steinberg12230809-01-010
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

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; Other: laboratory biomarker analysis

Interventions

cytology specimen collection procedure OTHER

Undergo blood sample collection

Also known as: cytologic sampling

Ancillary-Correlative (blood banking)

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-Correlative (blood banking)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cancer patients undergoing physician directed radiation treatment.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The tentative assumption is that cell death following radiation therapy will stimulate anti-tumor immunity, which could provide a more permanent solution to curing cancer and discouraging tumors from spreading throughout the body. In order to find out if this assumption is correct, highly developed, laboratory analyses for tumor-specific immunity will be performed using the white blood cells, while the blood components that are soluble, will be frozen and stored, to be examined at a later time for evidence of molecules of anti-tumor immunity that have been induced by radiation therapy.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael Steinberg

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: December 8, 2014
• Study Start: July 8, 2010
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-01

Locations

US (1)