Exosomes in Rectal Cancer

NCT03874559 | Recruiting DMC FDA Device

• 1 other identifier: Protocol IIT-RE-0
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

neoadjuvant chemoradiation therapy; Low anterior resection; abdominoperineal resection; exosomes; biomarkers; external beam radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Exosomal Expression

  up to 10 years after treatment completion

• Exosomal Functionality Assessment

  up to 10 years after treatment completion

Study Arms (1)

Arm A

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.

Diagnostic Test: Blood Draw

Interventions

Blood Draw DIAGNOSTIC_TEST

Serum samples will be obtained from each patient enrolled

Arm A

Eligibility Criteria

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

Study Population

All patients seen in the Department of Radiation Oncology at The University of Kansas Health System that are over the age of 18 and have a histologically proven diagnosis of rectal adenocarcinoma and will be receiving neoadjuvant chemoradiation therapy before a planned, definitive surgical resection has been performed.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center/ Cancer Center

Kansas City, Kansas, 66190, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood serum samples will be collected from patients before, during, and after chemoradiation therapy. These samples will be analyzed and stored for 10 years

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Hoover, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah K Miller, MS

CONTACT

913-588-3670; lmiller25@kumc.edu

Michelle Faucheux, RN

CONTACT

913-588-9927; mfaucheux@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 14, 2019
• Study Start: February 13, 2018
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)