Colorectal CancerCOCO-SNCT07237984
Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial summary
Colorectal Cancer (CRC), or bowel cancer, is a serious disease that affects many people globally. The earlier CRC is diagnosed, the better the patient outcomes. The problem with the current diagnostic methods is that they lead to many unnecessary endoscopies (colonoscopies). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Inflammatory Bowel Disease (IBD)
- What is being tested?
- Blood sampling and Stool samplong
- How many people
- 2,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Aug 2026to 31 Dec 2031
- 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: People living within the Capital Region of Denmark referred to a screening or colorectal cancer diagnostic pathway colonoscopy
Who may be able to join
- Patients planned to undergo a colonoscopy either as part of the colorectal cancer screening programme due to a positive FIT or within a 'cancer patient pathway' for CRC at one of the study sites.
- Able to speak Danish, English, or other languages with sufficient interpretation provided by relatives.
- Able to give informed consent
Who cannot join
- 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.
Christina Therkilsen, PhD MSc contact
Denmark2 sites, 2 recruiting
- Recruiting
Copenhagen University Hospital - North Zealand
Hillerød, 3400
Claus Anders Bertelsen, PhD MSc, +45 51 90 63 03, claus.anders.bertelsen@regionh.dk
- Recruiting
Copenhagen University Hospital - Amager-Hvidovre
Hvidovre, 2650
Christina Therkildsen, PhD MSc, christina.therkildsen@regionh.dk
About this study
Official title: Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans in Screening and Colorectal Cancer Diagnostic Pathway
Colorectal Cancer (CRC), or bowel cancer, is a serious disease that affects many people globally. The earlier CRC is diagnosed, the better the patient outcomes.
The problem with the current diagnostic methods is that they lead to many unnecessary endoscopies (colonoscopies). In Denmark alone, over 30,000 patients every year undergo a colonoscopy without having a serious disease. This puts a major strain on both patients and the healthcare system.
Read more
This research project aims to solve that problem. COCO-S is investigating oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) to see if ofCS can be used as a novel, unique cancer marker found in the blood.
ofCS are special molecules that reappear in most tumour tissues. A method has been developed to detect ofCSs in a simple blood sample.
Initial findings from an ongoing study are highly promising. A test using five different ofCS markers has shown very high accuracy in detecting CRC: it correctly identifies 86% of cancer cases (sensitivity) and correctly gives a "negative" result in 97% of cases without cancer (specificity).
The results also suggest that high ofCS levels might help clinicians detect adenomas (polyps), which are early precursors to cancer.
Combining the analysis of ofCS in the blood with the existing stool test (FIT) and other promising blood markers can significantly improve patient selection for a colonoscopy.
This project will collect blood samples from patients scheduled for a colonoscopy. The blood will be analysed for ofCS and other substances to determine the combined predictive value for patients who truly require the procedure.
The findings from this project could revolutionize CRC diagnosis. By more accurately identifying patients who need a colonoscopy, the number of unnecessary, invasive procedures can be reduced while maintaining patient safety and ensuring cancer is found in time.
Read the detailed description
Colorectal cancer (CRC) is a significant global health burden. Early detection improves outcomes, but current diagnostic pathways lead to many unnecessary colonoscopies. In Denmark, over 30,000 colonoscopies are performed annually on patients without any pathology, burdening both healthcare resources and patients.
This project aims to address this unmet clinical need by investigating the potential of oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) as a novel, tumour-specific biomarker for improved patient allocation to colonoscopy. OfCS are unique molecules that re-emerge in most cancer tissues and can be detected in blood plasma using a proprietary method developed.
Preliminary findings from an ongoing study in CRC patients are highly encouraging. A panel of five ofCS biomarkers has shown high accuracy in detecting CRC, with a cumulative AUC of 0.96, a sensitivity of 86%, and a specificity of 97%. Importantly, these results also suggest that elevated ofCS levels may help detect adenomas, an early precursor to CRC.
Incorporating ofCS analysis into existing diagnostic frameworks, such as the faecal immunochemical test (FIT), will significantly improve the accuracy of patient selection for colonoscopy.
The study assesses whether supplementing the FIT with ofCS analysis and other biomarkers from proteomics and metabolomics can yield a significantly higher AUC of the receiver operating characteristic (ROC) in both the screening and the 'cancer patient pathway'.
This prospective cohort study includes patients undergoing a colonoscopy. Participants blood will be analysed for ofCS, and proteomics and metabolomics biomarkers, to determine their combined predictive value.
The findings from this project could revolutionise CRC diagnosis by creating a tailor-made pathway. By more accurately identifying patients who need a colonoscopy, invasive procedures can be reduced while maintaining patient safety and cancer detection rates.
- Being tested
- Blood sampling, Stool samplong
- Keywords
- Biomarker, Colorectal Cancer, Glycoproteins, Proteomics
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Analyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers.
Stool samplongDiagnostic test
Fecal immunochemical test (FIT), feces sampled by the participant
| Study group | Role | What they receive |
|---|---|---|
| Coloretcal Screening Patients | In the Danish national colorectal cancer screening programme a full colonoscopy is recommended within 14 days colon after a positive (Faecal Immunochemical Test, FIT) test, defined as >100 µg Hgb/L (20 µg Hgb/g feces).
Patients referred to the study sites will be offered a single blood sample before bowel preparation for the colonoscopy. Receives: Diagnostic Test: Blood sampling | |
| Colorectal Cancer Pathway Patients | In Denmark, patients with symptoms aligning with a suspicion of colorectal cancer are by law to be offered a full colonoscopy within 14 days.
Patients referred to the study sites will be offered a single blood sample and a Faecal Immunochemical Test (FIT) before bowel preparation for the colonoscopy. Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Stool samplong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer
The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding colorectal cancer at colonoscopy
Measured: 30 days
Colorectal adenoma
The value of ofCS proteoglycans in blood plasma as a diagnostic test of detecting adenomas at colonoscopy
Measured: 30 days
Secondary outcomes (1)
Inflammatory bowel disease
The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding inflammatory bowel disease at colonoscopy
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 posted20 Nov 2025
- Study start11 Aug 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion31 Dec 2031 (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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Anders Bertelsen, PhD MD, Study chair, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237984
- Sponsor's protocol ID
- COCO-S
- Acronym
- COCO-S
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans in Screening and Colorectal Cancer Diagnostic Pathway
- ClinicalTrials.gov ID
- NCT07237984
- Acronym / sponsor ID
- COCO-S / COCO-S
- Keywords
- Biomarker, Colorectal Cancer, Glycoproteins, Proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 20 Nov 2025 (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.
Colorectal Cancer (CRC), or bowel cancer, is a serious disease that affects many people globally. The earlier CRC is diagnosed, the better the patient outcomes.
The problem with the current diagnostic methods is that they lead to many unnecessary endoscopies (colonoscopies). In Denmark alone, over 30,000 patients every year undergo a colonoscopy without having a serious disease. This puts a major strain on both patients and the healthcare system.
This research project aims to solve that problem. COCO-S is investigating oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) to see if ofCS can be used as a novel, unique cancer marker found in the blood.
ofCS are special molecules that reappear in most tumour tissues. A method has been developed to detect ofCSs in a simple blood sample.
Initial findings from an ongoing study are highly promising. A test using five different ofCS markers has shown very high accuracy in detecting CRC: it correctly identifies 86% of cancer cases (sensitivity) and correctly gives a "negative" result in 97% of cases without cancer (specificity).
The results also suggest that high ofCS levels might help clinicians detect adenomas (polyps), which are early precursors to cancer.
Combining the analysis of ofCS in the blood with the existing stool test (FIT) and other promising blood markers can significantly improve patient selection for a colonoscopy.
This project will collect blood samples from patients scheduled for a colonoscopy. The blood will be analysed for ofCS and other substances to determine the combined predictive value for patients who truly require the procedure.
The findings from this project could revolutionize CRC diagnosis. By more accurately identifying patients who need a colonoscopy, the number of unnecessary, invasive procedures can be reduced while maintaining patient safety and ensuring cancer is found in time.
Detailed description
Colorectal cancer (CRC) is a significant global health burden. Early detection improves outcomes, but current diagnostic pathways lead to many unnecessary colonoscopies. In Denmark, over 30,000 colonoscopies are performed annually on patients without any pathology, burdening both healthcare resources and patients.
This project aims to address this unmet clinical need by investigating the potential of oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) as a novel, tumour-specific biomarker for improved patient allocation to colonoscopy. OfCS are unique molecules that re-emerge in most cancer tissues and can be detected in blood plasma using a proprietary method developed.
Preliminary findings from an ongoing study in CRC patients are highly encouraging. A panel of five ofCS biomarkers has shown high accuracy in detecting CRC, with a cumulative AUC of 0.96, a sensitivity of 86%, and a specificity of 97%. Importantly, these results also suggest that elevated ofCS levels may help detect adenomas, an early precursor to CRC.
Incorporating ofCS analysis into existing diagnostic frameworks, such as the faecal immunochemical test (FIT), will significantly improve the accuracy of patient selection for colonoscopy.
The study assesses whether supplementing the FIT with ofCS analysis and other biomarkers from proteomics and metabolomics can yield a significantly higher AUC of the receiver operating characteristic (ROC) in both the screening and the 'cancer patient pathway'.
This prospective cohort study includes patients undergoing a colonoscopy. Participants blood will be analysed for ofCS, and proteomics and metabolomics biomarkers, to determine their combined predictive value.
The findings from this project could revolutionise CRC diagnosis by creating a tailor-made pathway. By more accurately identifying patients who need a colonoscopy, invasive procedures can be reduced while maintaining patient safety and cancer detection rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloretcal Screening Patients | – | Diagnostic Test: Blood samplingIn the Danish national colorectal cancer screening programme a full colonoscopy is recommended within 14 days colon after a positive (Faecal Immunochemical Test, FIT) test, defined as >100 µg Hgb/L (20 µg Hgb/g feces). Patients referred to the study sites will be offered a single blood sample before bowel preparation for the colonoscopy. |
| Colorectal Cancer Pathway Patients | – | Diagnostic Test: Blood sampling, Diagnostic Test: Stool samplongIn Denmark, patients with symptoms aligning with a suspicion of colorectal cancer are by law to be offered a full colonoscopy within 14 days. Patients referred to the study sites will be offered a single blood sample and a Faecal Immunochemical Test (FIT) before bowel preparation for the colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living within the Capital Region of Denmark referred to a screening or colorectal cancer diagnostic pathway colonoscopy
Key inclusion criteria (3 listed)
- Patients planned to undergo a colonoscopy either as part of the colorectal cancer screening programme due to a positive FIT or within a 'cancer patient pathway' for CRC at one of the study sites.
- Able to speak Danish, English, or other languages with sufficient interpretation provided by relatives.
- Able to give informed consent
Key exclusion criteria (3 listed)
- 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 |
|---|---|---|
| Blood samplingAnalyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers. | Diagnostic test | Colorectal Cancer Pathway Patients, Coloretcal Screening Patients |
| Stool samplongFecal immunochemical test (FIT), feces sampled by the participant | Diagnostic test | Colorectal Cancer Pathway Patients |
Primary outcome
Colorectal cancer
Time frame: 30 days
The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding colorectal cancer at colonoscopy
Colorectal adenoma
Time frame: 30 days
The value of ofCS proteoglycans in blood plasma as a diagnostic test of detecting adenomas at colonoscopy
1 secondary outcome
Inflammatory bowel disease
Time frame: 30 days
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Christina Therkilsen, PhD MSc contact
Claus Anders Bertelsen, PhD MD study chair
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 Colorectal Adenoma, run by Nordsjaellands Hospital 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 3 inclusion and 3 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 24 Aug 2026. 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 Claus Anders Bertelsen, PhD MD (+45 51 90 63 03, claus.anders.bertelsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer (time frame: 30 days). The study lists 2 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 24 Aug 2026.