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Search / Trial NCT04624555

The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors

Launched by CASE COMPREHENSIVE CANCER CENTER · Nov 5, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor colorectal cancer survivors by testing their stool for specific markers that could indicate the presence of polyps or cancer. This method is being compared to the standard testing currently used. The goal is to see if this stool test can help detect issues earlier and more effectively.

To participate in this trial, individuals must have been diagnosed with stage I, II, or III adenocarcinoma of the colon or rectum and have undergone surgery to remove part of their bowel. Unfortunately, those with more advanced cancer (stage IV) or certain other health conditions, such as inflammatory bowel disease or polyposis syndrome, cannot join. Participants will be asked to provide stool samples for testing, and they will be monitored closely during the study to see how well this new approach works. This research has the potential to improve how we follow up with colorectal cancer survivors, making it easier to catch any problems early on.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum
  • Receipt of preoperative colonoscopy
  • Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated
  • Exclusion Criteria:
  • Stage IV colorectal cancer
  • Surgical treatment with subtotal colectomy or total proctocolectomy
  • Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis
  • Presence of advanced adenomas (1 cm or larger, villous features and/or high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen.
  • Inability to provide informed consent
  • Inability to understand spoken and written English
  • Medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. These would be at the discretion of the participant's providers.

About Case Comprehensive Cancer Center

Case Comprehensive Cancer Center is a leading academic research institution dedicated to advancing cancer care through innovative clinical trials and cutting-edge research. As a National Cancer Institute-designated Comprehensive Cancer Center, it integrates multidisciplinary approaches to cancer prevention, diagnosis, and treatment, fostering collaboration among clinicians, researchers, and patients. The center is committed to translating scientific discoveries into effective therapies, enhancing patient outcomes, and contributing to the global body of cancer knowledge. With a robust portfolio of clinical trials, Case Comprehensive Cancer Center aims to address the unmet needs of cancer patients and drive progress in the fight against cancer.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Gregory Cooper, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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