Colorectal Omics and OfCS Proteoglycans (COCO)

Claus Anders Bertelsen, PhD, MD

Status

Enrolling

Conditions

Stoma Colostomy

Diverticulitis, Colonic

Inflammatory Bowel Diseases

Colorectal Cancer

Treatments

Procedure: Colorectal resection or stoma closure

Study type

Observational

Funder types

Other

Identifiers

NCT06287671

COCO

Details and patient eligibility

About

This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.

The main questions to answer are:

can these biomarkers predict anastomotic leakages
can these biomarkers predict recurrence after colorectal cancer
can these biomarkers be used as diagnostic tests for colorectal cancer
can these biomarkers be identified in the tumor

Participants will undergo elective colorectal resection or stoma closure.

Full description

The prospective cohort study will include 1,000 patients undergoing elective colorectal resections or colostomy reversal at two colorectal centers in Denmark. Repeating study blood samples will be collected on each postoperative day (POD) 1-4 or until discharge. If the participants are diagnosed with cancer, blood sampling is planned 26-35 days after the index procedure, and after one, two, and three years, a tumor biopsy will be taken from the fresh specimen in the operation theatre.

Analyses of blood plasma and tissue for oncofetal chondroitin sulfate (ofCS) proteoglycans, proteomics, and metabolomics will be performed on those repeating blood samplings to:

To investigate whether metabolomics, proteomics, and ofCS techniques can identify new biomarkers where charges in plasma levels can predict or detect subclinical AL (primary outcome) and other major postoperative complications after colorectal surgery and prediction of 90-day and three-year mortality.
To investigate whether the APOE genotype is associated with the risk of AL and other major postoperative complications and long-term outcomes, i.e., recurrence and mortality, after colorectal surgery.
To examine whether metabolomics and proteomics can identify new biomarkers predicting recurrence after colorectal cancer resections.
To identify other potential biomarkers that might enable early cancer diagnosis.
Whether proteoglycans can be used as a diagnostic test with a high degree of separability to identify tumor markers that are usable in a clinical setting (primary outcome). Participants with colorectal cancer will be compared with a control group of participants with benign conditions.
Whether the level of proteoglycans measured correlates to the tumor load.
Whether the proteoglycans and proteomics detected in plasma are presented in tumor tissue from the resected specimen.
Whether the proteoglycans detected can be used as tumor markers with a high degree or measure of separability for monitoring recurrence after colorectal cancer in a clinical setting (primary outcome).

Postoperative and follow-up data will be collected prospectively for the electronic health records.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed or with suspicion of colorectal cancer or adenoma, inflammatory bowel disease, late complications to colon diverticulosis, colostomy reversal or other diagnoses requiring colorectal resection.
Patients planned to undergo elective surgical procedures coded as KJFB20-KJFB99, KJFG30-37 or KJGB00-97 according to the Danish modification of the NOMESCO Classification of Surgical Procedures
Able to speak Danish, English, or other languages where professional interpretation is available
Able to give informed consent

Exclusion criteria

Patients undergoing synchronous: liver resection (patients undergoing metastasectomies can be included); total gastrectomy or cardia resection; Whipple's procedure or another major pancreatic resection (resections of the pancreatic tail can be included); total or partial nephrectomies or cystectomy
Patients previously included in the study
Patients known to be pregnant (pregnancy test not required)
Non-resident in Denmark