Colorectal Omics and OfCS Proteoglycans
Observational · No treatment assigned · 2 sites · Claus Anders Bertelsen, PhD, MD
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colorectal Cancer, Diverticulitis, Colonic and Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1000 participants are expected to take part.
- Start date: 2024-10-08.
- Main results expected around 2028-12-31 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in Denmark.
Main thing being measured
- Rate of anastomotic leakage diagnosed by CT-scan or reoperation (30 days)
In the researchers’ words
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 *…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colorectal Cancer; Diverticulitis, Colonic; Inflammatory Bowel Diseases; Stoma Colostomy |
| Lead sponsor | Claus Anders Bertelsen, PhD, MD |
| Collaborators | Viborg Regional Hospital |
| Enrollment | 1000 (estimated) |
| Start date | 2024-10-08 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2024-03-01 |
| Last updated | 2024-12-30 |
| Official title | Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans |
| ClinicalTrials.gov ID | NCT06287671 |
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
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Nordsjaellands Hospital | Hillerød | Denmark | Recruiting |
| Regionshospitalet Viborg | Viborg | Denmark | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.