Exosomes in Rectal Cancer

Recruiting

• Conditions: Rectal Cancer
• Interventions: Diagnostic Test: Blood Draw

• Registration Number: NCT03874559
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

Detailed Description

All male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 FU or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 Gy in 28 fractions. Radiation treatments will be administered daily, Monday thru Friday. Within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. Patients will also have serum samples collected every two weeks during radiation, and on the last day of radiation therapy, as well as at their one month follow up visit after completion of radiation and prior to planned surgery. A final serum sample will be collected within one month after definitive surgery. Each serum sample collected will be less than 50 mL.

The study will involve obtaining serum samples from patients before during and after chemoradiation therapy. These serum samples will be analyzed to determine exosomal biomarker levels, which will be correlated with clinical, imaging, laboratory, and pathologic data obtained from the medical record.

Additional data from the patients' medical records will be collected, including demographic data, clinical information from notes in the medical record, radiology images and reports, results of diagnositic tests, and information from procedure notes and pathology reports.

Study Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male and Female Patients aged 18 and older
• histologically proven diagnosis of rectal adenocarcinoma
• will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection

Exclusion Criteria

• Age less than 18.
• Patients who are unable or unwilling to undergo definitive surgery.
• Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy.
• Patients with a prior history of cancer (excluding non-melanoma skin cancers).
• Patients who are immunocompromised.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A	Blood Draw	All patients enrolled will be placed in Arm A. Serum blood draw samples will be collected as well as additional data from medical records will be collected. This data includes demographic data, clinical information from notes, radiology images and reports, diagnostic test results, and procedure and pathology reports.

Primary Outcome Measures

Name	Time	Method
Exosomal Biomarkers Assessment	up to 10 years after treatment completion	Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.

Secondary Outcome Measures

Name	Time	Method
Exosomal Expression	up to 10 years after treatment completion	Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. Response rates will be graded based on College of American Pathologists Guidelines on neoadjuvant treatment effect, which consist of a 4 tiered grading system categorizing response to neoadjuvant chemoradiation as "complete", "moderate", "minimal", or "poor". These grades are routinely documented in pathology reports for patients undergoing neoadjuvant chemoradiation for rectal cancer and will be obtained from review of pathology reports in the patient medical records.
Exosomal Functionality Assessment	up to 10 years after treatment completion	Examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

Trial Locations

Locations (1)

University of Kansas Medical Center/ Cancer Center; 🇺🇸 Kansas City, Kansas, United States