RECRUITING

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

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Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the RectumStage I Colorectal CancerStage II Colorectal CancerStage III Colorectal Cancer

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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 purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing.

Official Title

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

Quick Facts

Study Start:2022-10-31
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04624555

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. * Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum
  2. * Receipt of preoperative colonoscopy
  3. * Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated
  1. * Stage IV colorectal cancer
  2. * Surgical treatment with subtotal colectomy or total proctocolectomy
  3. * Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  4. * Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis
  5. * 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.
  6. * Inability to provide informed consent
  7. * Inability to understand spoken and written English
  8. * 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.

Contacts and Locations

Study Contact

Gregory Cooper, MD
CONTACT
1-800-641-2422
gregory.cooper@uhhospitals.org

Principal Investigator

Gregory Cooper, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Locations (Sites)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Gregory Cooper, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer 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 Date2022-10-31
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-10-31
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Stage I Colorectal Cancer
  • Stage II Colorectal Cancer
  • Stage III Colorectal Cancer