RECRUITING

Exosomes in Rectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-02-13
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03874559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female Patients aged 18 and older
  2. * histologically proven diagnosis of rectal adenocarcinoma
  3. * will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection
  1. * Age less than 18.
  2. * Patients who are unable or unwilling to undergo definitive surgery.
  3. * Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy.
  4. * Patients with a prior history of cancer (excluding non-melanoma skin cancers).
  5. * Patients who are immunocompromised.

Contacts and Locations

Study Contact

Leah K Miller, MS
CONTACT
913-588-3670
lmiller25@kumc.edu
Michelle Faucheux, RN
CONTACT
913-588-9927
mfaucheux@kumc.edu

Principal Investigator

Andrew Hoover, MD
PRINCIPAL_INVESTIGATOR
The University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center/ Cancer Center
Kansas City, Kansas, 66190
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Andrew Hoover, MD, PRINCIPAL_INVESTIGATOR, The University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-13
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2018-02-13
Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Rectal Cancer