Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-10-08
2032-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study cohort
Patients undergoing elective colorectal resection or stoma closure
Colorectal resection or stoma closure
Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure
Interventions
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Colorectal resection or stoma closure
Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure
Eligibility Criteria
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Inclusion Criteria
* 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 previously included in the study
* Patients known to be pregnant (pregnancy test not required)
* Non-resident in Denmark
18 Years
ALL
No
Sponsors
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Viborg Regional Hospital
OTHER
Claus Anders Bertelsen, PhD, MD
OTHER
Responsible Party
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Claus Anders Bertelsen, PhD, MD
Clinical research professor, consultant colorectal surgeon
Principal Investigators
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Claus A Bertelsen, PhD
Role: STUDY_CHAIR
Department of Surgery, Copenhagen University Hospital - North Zealand
Locations
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Nordsjaellands Hospital
Hillerød, , Denmark
Regionshospitalet Viborg
Viborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Nanna B Hupfeld, MD
Role: primary
Claus A Bertelsen, PhD
Role: backup
Anders S Tøttrup, PhD
Role: primary
Other Identifiers
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COCO
Identifier Type: -
Identifier Source: org_study_id