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 * can these biomarkers be identified in the tumor 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: * To investigate whether metabolomics, proteomics, and ofCS techniques can identify new biomarkers where charges in plasma levels can predict or detect subclinical AL (primary outcome) and other major postoperative complications after colorectal surgery and prediction of 90-day and three-year mortality. * To investigate whether the APOE genotype is associated with the risk of AL and other major postoperative complications and long-term outcomes, i.e., recurrence and mortality, after colorectal surgery. * To examine whether metabolomics and proteomics can identify new biomarkers predicting recurrence after colorectal cancer resections. * To identify other potential biomarkers that might enable early cancer diagnosis. * Whether proteoglycans can be used as a diagnostic test with a high degree of separability to identify tumor markers that are usable in a clinical setting (primary outcome). Participants with colorectal cancer will be compared with a control group of participants with benign conditions. * Whether the level of proteoglycans measured correlates to the tumor load. * Whether the proteoglycans and proteomics detected in plasma are presented in tumor tissue from the resected specimen. * Whether the proteoglycans detected can be used as tumor markers with a high degree or measure of separability for monitoring recurrence after colorectal cancer in a clinical setting (primary outcome). Postoperative and follow-up data will be collected prospectively for the electronic health records.
Study Type
OBSERVATIONAL
Enrollment
1,000
Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure
Nordsjaellands Hospital
Hillerød, Denmark
RECRUITINGRegionshospitalet Viborg
Viborg, Denmark
NOT_YET_RECRUITINGRate 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
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