Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome

Completed

• Conditions: Prostate Cancer; Breast Cancer

• Registration Number: NCT03383107
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

Exposure to radiation can impact immune cells that are present in the blood, such as lymphocytes. It is hypothesized that larger radiation fields and/or longer courses of radiation, result in greater decrease in immune cells. To test this hypothesis, investigators will take blood samples from subjects undergoing two different standard of care radiation regimens for prostate cancer, and subjects undergoing two different standard of care regimens for breast cancer.

Detailed Description

The study prospectively collects blood specimens for assessment of peripheral immune mediators in 4 distinct clinical settings of standard radiotherapy. In addition to collecting blood specimens, the study will also collect physical and dosimetric information of treatment such as total dose, number of treatments, and/or size of the radiation targe, as these will allow the investigators to study the impact of radiation variables on the immune system. Stool specimens will be collected at baseline, end of radiation therapy and during the follow up visit to detect microbiome changes associated with different radiation treatment at various time points. Humans are colonized by commensal bacteria, which outnumber human cells. These normal bacteria colonize mucosal surfaces and play a critical role in immunity. It is hypothesized that the underlying microbiota may also undergo changes in composition that correspond to the regimen of radiation that is utilized. By collecting stool specimens, investigators will be able to study microbial changes and how these changes correlate with alteration in immune mediators (i.e., lymphocytes, cytokines) present in blood samples before, during and after radiation; and explore the association between these parameters and type of radiation received.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-26
• Study Start: 2018-01-22
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prospectively collecting blood specimens to assess peripheral immune mediatiors in 4 distinct clinical settings	4 years	prospectively collect collect physical and dosimetric information of treatment and sequential blood samples for assessment of peripheral immune mediators in 4 distinct clinical settings of standard radiotherapy (2 for breast and 2 for prostate cancer)
distribution and frequency of peripheral immune mediators before, during and after radiotherapy will be assessed from blood samples that are collected at various time points	4 years	To characterize the distribution and frequency of peripheral immune mediators before, during and after radiotherapy in each of the 4 subsets of the prospective trial.

Secondary Outcome Measures

Name	Time	Method
microbiome changes associated with different radiation treatments through collection of stool microbiome samples at different time points	4 years	explore microbiome changes associated with different radiation treatments through collection of stool microbiome samples at baseline, at the end of radiation therapy, and during follow up after completion of Radiotherapy

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States