Breast Cancer, Prostate Cancer
Conditions
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.
Interventions
None listed
Sponsors
Varian Medical Systems
Weill Medical College of Cornell University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Cohort 1a and b: Prostate cancer subjects undergoing 9 week radiation Inclusion criteria: * Biopsy-proven diagnosis of prostate adenocarcinoma * Age ≥ 18
Exclusion criteria
* History of prior pelvic radiation (external beam or brachytherapy) * Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years * History of hormone therapy such as LHRH agonists (gosrelin, leuprolide), anti-androgens (flutamide, bicalutamide), surgical castration (orchiectomy) * History of irritable bowel disease * Evidence of lymph node involvement or metastatic disease Cohort 2a : Breast cancer subjects undergoing standard fractionation RT of 5 weeks Inclusion criteria: * Biopsy-proven diagnosis of invasive breast cancer, s/p breast surgery to negative margins, and requiring adjuvant breast and nodal RT * Age ≥ 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed