Actively Recruiting
Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans
Led by Claus Anders Bertelsen, PhD, MD · Updated on 2024-12-30
1000
Participants Needed
2
Research Sites
208 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 conducting an observational study to explore if proteomics, metabolomics, and proteoglycans can predict postoperative complications and serve as biomarkers for colorectal cancer. The study focuses on whether these biomarkers can detect anastomotic leakages, predict cancer recurrence, act as diagnostic tests, and be identified in tumor tissue. Participants include patients undergoing elective colorectal surgery or stoma closure, including those with colorectal cancer or benign colorectal diseases. Participants will undergo elective colorectal resections or colostomy reversals using either open or minimally invasive techniques. Blood samples will be collected daily from postoperative day 1 to day 4 or until discharge, with additional follow-up sampling at specific intervals up to three years for those diagnosed with cancer. Tumor biopsies will be taken from surgical specimens during the operation to analyze proteoglycans and other markers. Throughout the study, researchers will collect data from blood plasma and tissue to identify biomarkers predicting postoperative complications and cancer outcomes. Medical records will be reviewed prospectively for complications and mortality up to 90 days, and cancer recurrence will be tracked for up to four years. The study aims to correlate biomarker levels in plasma with tumor tissue and evaluate their diagnostic and monitoring potential for colorectal cancer.
CONDITIONS
Brief Title
Colorectal Omics and OfCS Proteoglycans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed or suspected of colorectal cancer, adenoma, inflammatory bowel disease, late complications from colon diverticulosis, colostomy reversal, or other conditions requiring colorectal resection
- Planned for elective surgical procedures coded as KJFB20-KJFB99, KJFG30-37, or KJGB00-97 according to Danish NOMESCO Classification
- Able to speak Danish, English, or a language with professional interpretation available
- Able to provide informed consent
You will not qualify if you...
- Undergoing synchronous liver resection (except metastasectomy), total gastrectomy, cardia resection, Whipple's procedure, or major pancreatic resection (except pancreatic tail resection)
- Previously enrolled in this study
- Known to be pregnant
- Non-resident of Denmark
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Day of surgery
Participants undergo elective colorectal resection or stoma closure as part of their clinical care.
1 hospital visit for the surgical procedure
Duration - Up to 4 days post-surgery
Participants have blood samples collected daily on postoperative days 1 to 4 or until discharge to analyze biomarkers related to surgical outcomes.
Daily blood sampling visits for up to 4 days or until discharge
Duration - Up to 3 years post-surgery
Participants diagnosed with cancer have additional blood sampling approximately 26 to 35 days after surgery, and tumor biopsies are taken during surgery. Further tumor biopsies are planned at one, two, and three years after surgery to monitor long-term outcomes.
1 blood sampling visit 26-35 days post-surgery and yearly tumor biopsy visits at 1, 2, and 3 years
Duration - Up to 4 years
Participants are monitored over time to assess recurrence, complications, and mortality through ongoing data collection from health records and biomarker analyses.
Annual visits corresponding with tumor biopsy collection for up to 3 years; ongoing health record monitoring
Trial Site Locations
Total: 2 locations
1
Nordsjaellands Hospital
Hillerød, Denmark, 3400
Actively Recruiting
2
Regionshospitalet Viborg
Viborg, Denmark, 8800
Not Yet Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here