Plasma 5hmC Signatures as a Marker of Colorectal / Appendiceal Peritoneal Metastasis

NCT04157322 | Active Not Recruiting

• 1 other identifier: IRB19-0913
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with peritoneal metastasis of colorectal or high grade appendiceal origin who are candidates for cytoreductive surgery with HIPEC (hyperthermic intraperitoneal chemotherapy) will be enrolled in this study. Blood collection for measurements of plasma cell-free DNA hydroxymethylation signatures will be performed at different time points, before and after surgery, in order to determine if plasma hydroxymethylation signatures are more sensitive than conventional tumor markers in identifying clinically detectable recurrence at 1 year after surgery.

Conditions

Colorectal Cancer Stage IV; Colorectal Cancer Metastatic; Colorectal Cancer, Genetics of; Appendix Cancer

Outcome Measures

Primary Outcomes (1)

• clinically detectable recurrence at 1 year after surgery.

  1. Clear radiological evidence of recurrent disease. 2. Histopathological proof (by means of endoscopy, imaging guided biopsy or diagnostic surgery) of recurrent disease. 3. A new lesion revealed by physical examination

  5 years

Interventions

prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study DIAGNOSTIC_TEST

Blood draw

Eligibility Criteria

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

Study Population

Adult patients with peritoneal metastasis of colorectal or high grade appendiceal origin who are candidates for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

You may qualify if:

• I. Histologic proof of colorectal adenocarcinoma or high grade appendiceal tumors (appendiceal adenocarcinoma or ex-goblet adenocarcinoma Tang B or C).
• II. Age ≥ 18 years. III. Patients with known peritoneal metastasis (PM) who are candidates for complete cytoreduction and HIPEC. Known PM - diagnosed previously by diagnostic laparoscopy / laparotomy or clear radiological evidence of PM.
• IV. Neoadjuvant chemotherapy permitted. V. The patient is able to provide informed consent. VI. The patient is planned to undergo his / her postoperative surveillance at UCM, as this study's protocol requires multiple clinic visits.
• VII. No evidence of systemic metastasis.

You may not qualify if:

• Vulnerable subjects will not participate in this study.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Colorectal Neoplasms; Appendiceal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cecal Neoplasms; Cecal Diseases

Study Officials

• Bruce Bissonnette, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: August 26, 2019
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

US (1)