An observational study in Colorectal Cancer, Diverticulitis, Colonic and Inflammatory Bowel Diseases, sponsored by Claus Anders Bertelsen, PhD, MD. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Claus Anders Bertelsen, PhD, MD · Observational
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:
Participants will undergo elective colorectal resection or stoma closure.
The prospective cohort study will include 1,000 patients undergoing elective colorectal resections or colostomy reversal at two colorectal centers in Denmark. Repeating study blood samples will be collected on each postoperative day (POD) 1-4 or until discharge. If the participants are diagnosed with cancer, blood sampling is planned 26-35 days after the index procedure, and after one, two, and three years, a tumor biopsy will be taken from the fresh specimen in the operation theatre.
Analyses of blood plasma and tissue for oncofetal chondroitin sulfate (ofCS) proteoglycans, proteomics, and metabolomics will be performed on those repeating blood samplings to:
Postoperative and follow-up data will be collected prospectively for the electronic health records.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Claus Anders Bertelsen, PhD, MD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients planned for elective colorectal surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing elective colorectal resection or stoma closure
Procedure: Colorectal resection or stoma closure
Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure
Rate of anastomotic leakage diagnosed by CT-scan or reoperation
Anastomotic leakage after colorectal resection with anastomosis or stoma closure
Time frame: 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
Time frame: 30 days
Short-term mortality
Postoperative mortality after colorectal resection with anastomosis or stoma closure
Time frame: 90 days
Recurrence after colorectal cancer
Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy
Time frame: 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
Time frame: 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
Time frame: 30 days
Plan to share: No — Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. After acceptance from the participant and the ethics committee of the Capital Region of Denmark, individual participant data and blood plasma will be available to potential collaborators interested in colorectal disorders.
No publications or documents are linked to this record.
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Claus Anders Bertelsen, PhD, MD