Colorectal Omics and OfCS Proteoglycans

NCT06287671 | Recruiting

• 1 other identifier: COCO
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer; Diverticulitis, Colonic; Inflammatory Bowel Diseases; Stoma Colostomy

Outcome Measures

Primary Outcomes (6)

• Rate of anastomotic leakage diagnosed by CT-scan or reoperation

  Anastomotic leakage after colorectal resection with anastomosis or stoma closure

  30 days

• Rate of major postoperative complications

  Major postoperative complication (Clavien-Dindo score 3B or higher, and DVT and pulmonary embolism) after colorectal resection with anastomosis or stoma closure

  30 days

• Short-term mortality

  Postoperative mortality after colorectal resection with anastomosis or stoma closure

  90 days

• Recurrence after colorectal cancer

  Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy

  4 years

• Diagnostic value of omics and other biomarkers detecting colorectal cancer

  Identifying omics and chondroitin sulfate-modified proteoglycans that can be used i a clinical setting to identify colorectal cancer patients

  30 days

• Correlation between biomarker in plasma and tissue

  Does presence of tumor markers in blood plasma correlate with the same tumor makers in the tumor tissue

  30 days

Study Arms (1)

Study cohort

Patients undergoing elective colorectal resection or stoma closure

Procedure: Colorectal resection or stoma closure

Interventions

Colorectal resection or stoma closure PROCEDURE

Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure

Study cohort

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

Patients planned for elective colorectal surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Claus Anders Bertelsen, PhD, MD: lead
• Viborg Regional Hospital: collaborator

Study Sites (2)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

RECRUITING

Regionshospitalet Viborg

Viborg, 8800, Denmark

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma Tumor tissue from participants with colorectal cancer

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticulitis, Colonic; Inflammatory Bowel Diseases

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; Diverticulitis; Diverticular Diseases; Gastroenteritis; Diverticulosis, Colonic

Study Officials

• Claus A Bertelsen, PhD

  Department of Surgery, Copenhagen University Hospital - North Zealand

  STUDY CHAIR

Central Study Contacts

Nanna B Hupfeld, ph.d.

CONTACT

+4548292793; nanna.baekvang.hupfeld.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical research professor, consultant colorectal surgeon

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 1, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)