Colorectal CancerCOCONCT06287671
Colorectal Omics and OfCS Proteoglycans
An observational study of Colorectal Cancer and Diverticulitis, Colonic, run by Claus Anders Bertelsen, PhD, MD at 2 sites in Denmark.
Trial summary
This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Diverticulitis, Colonic, Inflammatory Bowel Diseases
- What is being tested?
- Colorectal resection or stoma closure
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 Oct 2024to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for elective colorectal surgery
Who may be able to join
- Patients diagnosed or with suspicion of colorectal cancer or adenoma, inflammatory bowel disease, late complications to colon diverticulosis, colostomy reversal or other diagnoses requiring colorectal resection.
- 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
Who cannot join
- Patients undergoing synchronous: liver resection (patients undergoing metastasectomies can be included); total gastrectomy or cardia resection; Whipple's procedure or another major pancreatic resection (resections of the pancreatic tail can be included); total or partial nephrectomies or cystectomy
- Patients previously included in the study
- Patients known to be pregnant (pregnancy test not required)
- Non-resident in Denmark
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Nordsjaellands Hospital
Hillerød, 3400
Nanna B Hupfeld, MD, +4548292793, nanna.baekvang.hupfeld.01@regionh.dk
Claus A Bertelsen, PhD, +4548295972, claus.anders.bertelsen@regionh.dk
- Not yet recruiting
Regionshospitalet Viborg
Viborg, 8800
Anders S Tøttrup, PhD, andetoet@rm.dk
About this study
Official title: Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans
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.
Read the detailed description
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.
- Being tested
- Colorectal resection or stoma closure
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis, Colonic, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal resection or stoma closureProcedure or surgery
Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients undergoing elective colorectal resection or stoma closure Receives: Procedure: Colorectal resection or stoma closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomotic leakage diagnosed by CT-scan or reoperation
Anastomotic leakage after colorectal resection with anastomosis or stoma closure
Measured: 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
Measured: 30 days
Short-term mortality
Postoperative mortality after colorectal resection with anastomosis or stoma closure
Measured: 90 days
Recurrence after colorectal cancer
Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy
Measured: 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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start8 Oct 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claus Anders Bertelsen, PhD, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Viborg Regional Hospital
- Responsible party
- Sponsor-investigator, Claus Anders Bertelsen, PhD, MD, Nordsjaellands Hospital
- Investigators
- Claus A Bertelsen, PhD, Study chair, Department of Surgery, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287671
- Sponsor's protocol ID
- COCO
- Acronym
- COCO
- Status last verified
- Dec 2024
- First submitted
- 22 Feb 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans
- ClinicalTrials.gov ID
- NCT06287671
- Acronym / sponsor ID
- COCO / COCO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Claus Anders Bertelsen, PhD, MDUniversity, hospital or other
- Collaborators
- Viborg Regional Hospital
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Procedure: Colorectal resection or stoma closurePatients undergoing elective colorectal resection or stoma closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for elective colorectal surgery
Key inclusion criteria (4 listed)
- Patients diagnosed or with suspicion of colorectal cancer or adenoma, inflammatory bowel disease, late complications to colon diverticulosis, colostomy reversal or other diagnoses requiring colorectal resection.
- 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
Key exclusion criteria (4 listed)
- Patients undergoing synchronous: liver resection (patients undergoing metastasectomies can be included); total gastrectomy or cardia resection; Whipple's procedure or another major pancreatic resection (resections of the pancreatic tail can be included); total or partial nephrectomies or cystectomy
- Patients previously included in the study
- Patients known to be pregnant (pregnancy test not required)
- Non-resident in Denmark
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal resection or stoma closureElective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure | Procedure or surgery | Study cohort |
Primary outcome
Rate of anastomotic leakage diagnosed by CT-scan or reoperation
Time frame: 30 days
Anastomotic leakage after colorectal resection with anastomosis or stoma closure
Rate of major postoperative complications
Time frame: 30 days
Major postoperative complication (Clavien-Dindo score 3B or higher, and DVT and pulmonary embolism) after colorectal resection with anastomosis or stoma closure
Short-term mortality
Time frame: 90 days
Postoperative mortality after colorectal resection with anastomosis or stoma closure
Recurrence after colorectal cancer
Time frame: 4 years
Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy
Diagnostic value of omics and other biomarkers detecting colorectal cancer
Time frame: 30 days
Identifying omics and chondroitin sulfate-modified proteoglycans that can be used i a clinical setting to identify colorectal cancer patients
Correlation between biomarker in plasma and tissue
Time frame: 30 days
Does presence of tumor markers in blood plasma correlate with the same tumor makers in the tumor tissue
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claus A Bertelsen, PhD study chair
Department of Surgery, Copenhagen University Hospital - North Zealand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Diverticulitis, Colonic, run by Claus Anders Bertelsen, PhD, MD at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanna B Hupfeld, ph.d. (+4548292793, nanna.baekvang.hupfeld.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomotic leakage diagnosed by CT-scan or reoperation (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.