Exosomes in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874559
• Other study ID #: Protocol IIT-RE-0
• Status: Recruiting
• Start date: February 13, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2019
• Source: University of Kansas Medical Center
• Contact: Leah K Miller, MS
• Phone: 913-588-3670
• Email: lmiller25[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Diagnostic Test:
• Blood Draw
Serum samples will be obtained from each patient enrolled

Locations

Country	Name	City	State
United States	University of Kansas Medical Center/ Cancer Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exosomal Biomarkers Assessment	Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.	up to 10 years after treatment completion
Secondary	Exosomal Expression	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.	up to 10 years after treatment completion
Secondary	Exosomal Functionality Assessment	Examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.	up to 10 years after treatment completion