Investigating biomarkers for complications after colorectal surgery
Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans
This study is testing if certain blood markers can help predict complications after colorectal surgery and improve early cancer diagnosis for patients undergoing these procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 2 sites (Hillerød and 1 other locations) |
| Trial ID | NCT06287671 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of proteomics, metabolomics, and proteoglycans as predictors of postoperative complications following colorectal surgery and as potential biomarkers for colorectal cancer. It will involve a cohort of 1,000 patients undergoing elective colorectal resections or stoma closures at two centers in Denmark. Blood samples will be collected on postoperative days and analyzed to identify biomarkers that may predict anastomotic leakages, cancer recurrence, and aid in early cancer diagnosis. The study will also explore the association of the APOE genotype with postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with or suspected of having colorectal cancer, inflammatory bowel disease, or other conditions requiring colorectal surgery.
Not a fit: Patients undergoing major pancreatic resections or those with synchronous liver resections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of postoperative complications and cancer recurrence in colorectal surgery patients.
How similar studies have performed: While similar studies have explored biomarkers in colorectal surgery, this specific approach focusing on proteomics and metabolomics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hillerød and 1 other locations
- Nordsjaellands Hospital — Hillerød, Denmark (Recruiting)
- Regionshospitalet Viborg — Viborg, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Nanna B Hupfeld, ph.d.
- Email: nanna.baekvang.hupfeld.01@regionh.dk
- Phone: +4548292793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.