Actively Recruiting

Age: 18Years +
All Genders
ID06287671

Colorectal Omics and Oncofetal Chondroitin Sulfate-modified Proteoglycans An Observational Study to Identify Biomarkers Predicting Complications and Cancer Outcomes in Patients Undergoing Elective Colorectal Surgery

Led by Claus Anders Bertelsen, PhD, MD · Updated on 2024-12-30

1000

Participants Needed

2

Research Sites

429 weeks

Total Duration

On this page

Sponsors

C

Claus Anders Bertelsen, PhD, MD

Lead Sponsor

V

Viborg Regional Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of proteomics, metabolomics, and oncofetal chondroitin sulfate-modified proteoglycans as predictors of postoperative complications and biomarkers for colorectal cancer. This observational study focuses on whether these biomarkers can predict anastomotic leakages, cancer recurrence, and serve as diagnostic tests, including identifying biomarkers present in tumor tissue. The study will include patients undergoing elective colorectal surgery or stoma closure. Participants will have elective open or minimally invasive colorectal resections or stoma closures for conditions such as colorectal cancer, inflammatory bowel disease, diverticulitis, or other benign colorectal disorders. Blood samples will be collected daily for up to four days after surgery and at specific intervals up to three years if cancer is diagnosed. Tumor biopsies will be taken during surgery to analyze proteoglycans and other biomarkers. During the study, researchers will collect blood and tissue samples to analyze biomarkers related to postoperative complications, cancer recurrence, and diagnosis. They will monitor outcomes such as anastomotic leakage rates, major complications within 30 days, mortality at 90 days, and cancer recurrence over four years. Data will be gathered from electronic health records, and the study aims to correlate biomarker levels with tumor presence and patient outcomes.

CONDITIONS

Official Title

Colorectal Omics and OfCS Proteoglycans

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed or suspected of colorectal cancer or adenoma, inflammatory bowel disease, late complications from colon diverticulosis, colostomy reversal, or other conditions needing colorectal resection
  • Patients scheduled for elective surgical procedures coded KJFB20-KJFB99, KJFG30-37, or KJGB00-97 per Danish NOMESCO Classification
  • Able to speak Danish, English, or other languages with professional interpretation
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Patients undergoing synchronous liver resection, total gastrectomy or cardia resection, Whipple's procedure or major pancreatic resection, or total/partial nephrectomy or cystectomy (except pancreatic tail resection and metastasectomies)
  • Patients previously enrolled in the study
  • Patients known to be pregnant
  • Non-residents of Denmark

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nordsjaellands Hospital

Hillerød, Denmark, 3400

Actively Recruiting

2

Regionshospitalet Viborg

Viborg, Denmark, 8800

Not Yet Recruiting

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Research Team

N

Nanna B Hupfeld, ph.d.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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