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| Name | Class |
|---|---|
| Viborg Regional Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Patients undergoing elective colorectal resection or stoma closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal resection or stoma closure | Procedure | Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of anastomotic leakage diagnosed by CT-scan or reoperation | Anastomotic leakage after colorectal resection with anastomosis or stoma closure | 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 | 30 days |
| Short-term mortality | Postoperative mortality after colorectal resection with anastomosis or stoma closure | 90 days |
| Recurrence after colorectal cancer | Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy | 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 | 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 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients planned for elective colorectal surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nanna B Hupfeld, ph.d. | Contact | +4548292793 | nanna.baekvang.hupfeld.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Claus A Bertelsen, PhD | Department of Surgery, Copenhagen University Hospital - North Zealand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordsjaellands Hospital | Recruiting | Hillerød | 3400 | Denmark |
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.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004239 | Diverticulitis, Colonic |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Blood plasma Tumor tissue from participants with colorectal cancer
| Regionshospitalet Viborg | Not yet recruiting | Viborg | 8800 | Denmark |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004238 | Diverticulitis |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D043963 | Diverticulosis, Colonic |