Colorectal Cancer (CRC)CLIMBEDNCT07168876
Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)
An observational study of Colorectal Cancer (CRC), run by Epiliquid Holding, Inc at 1 site in Argentina.
Trial summary
CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Delta-HLD, Epiliquid's proprietary liquid biopsy technology, for colorectal cancer (CRC)… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC)
- How many people
- 3,200 participants
- Where
- 1 siteArgentina
- Study dates
- 4 Apr 2024to Dec 2028
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Single cohort of adults aged 45 and 75 years, representing an average-risk CRC population, undergoing routine colorectal cancer screening with colonoscopy in Argentina as standard of care.
Who may be able to join
- Men and women aged 45-75 years
- Indication of colorectal cancer screening colonoscopy by treating physician
Who cannot join
- First-degree family history of CRC
- Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- Other malignancies within 5 years
- Known hereditary CRC syndromes (Lynch, FAP)
- Major trauma, surgery, transfusion in past 30 days
- Current participation in an interventional clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Epiliquid
Mendoza, Mendoza Province, 5500
Alejandro Ledesma, M.Sc, +549 1140681732, alejandro.ledesma@epiliquid.com
About this study
Official title: Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)
CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Delta-HLD, Epiliquid's proprietary liquid biopsy technology, for colorectal cancer (CRC) detection. The study will evaluate the test performance in an average-risk population for CRC undergoing screening colonoscopy, which will serve as the gold standard reference.
Read the detailed description
Colorectal cancer (CRC) is one of the most common cancers worldwide and among the leading causes of cancer-related mortality. Early detection substantially improves survival; however, adherence to existing screening strategies remains suboptimal across different regions. CLIMBED is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Epiliquid's Delta-HLD liquid biopsy technology, which detects methylation-based epigenetic biomarkers in plasma using PCR. The study will enroll 3200 participants between 45 and 75 years of age, representing an average-risk CRC population. All participants will undergo screening colonoscopy, which will serve as the gold standard for comparison. The primary endpoints are sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Delta-HLD technology for CRC detection in cfDNA. Secondary endpoints include the capacity of the test to identify precursor lesions. Statistical analysis will be based on ROC curves and AUC to determine diagnostic performance.
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Colorectal cancer, Epigenetics, Liquid biopsy, cfDNA, Biomarker, Methylarion, PCR
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases: Average-risk population undergoing colorectal cancer screening colonoscopy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of colorectal cancer detection
Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer
Measured: 18 months
Specificity of advanced neoplasia detection
Specificity of colorectal cancer detection
Measured: 36 months
Secondary outcomes (2)
Accuracy of colorectal cancer precursor lesions detection
Sensitivity and specificity of of colorectal cancer precursor lesions detection
Measured: 36 months
Predictive values
Positive predictive value (PPV) and negative predictive value (NPV) of the Delta-HLD test for CRC detection
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start4 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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
- Cross-sectional
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epiliquid Holding, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuel Campoy, PhD, Study director, CONICET-National Scientific and Technical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168876
- Sponsor's protocol ID
- CRC-CV
- Other IDs
- RENIS IS004624
- Acronym
- CLIMBED
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)
- ClinicalTrials.gov ID
- NCT07168876
- Acronym / sponsor ID
- CLIMBED / CRC-CV
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Colorectal cancer, Epigenetics, Liquid biopsy, cfDNA, Biomarker, Methylarion, PCR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Epiliquid Holding, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Sep 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.
CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Delta-HLD, Epiliquid's proprietary liquid biopsy technology, for colorectal cancer (CRC) detection. The study will evaluate the test performance in an average-risk population for CRC undergoing screening colonoscopy, which will serve as the gold standard reference.
Detailed description
Colorectal cancer (CRC) is one of the most common cancers worldwide and among the leading causes of cancer-related mortality. Early detection substantially improves survival; however, adherence to existing screening strategies remains suboptimal across different regions. CLIMBED is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Epiliquid's Delta-HLD liquid biopsy technology, which detects methylation-based epigenetic biomarkers in plasma using PCR. The study will enroll 3200 participants between 45 and 75 years of age, representing an average-risk CRC population. All participants will undergo screening colonoscopy, which will serve as the gold standard for comparison. The primary endpoints are sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Delta-HLD technology for CRC detection in cfDNA. Secondary endpoints include the capacity of the test to identify precursor lesions. Statistical analysis will be based on ROC curves and AUC to determine diagnostic performance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases: Average-risk population undergoing colorectal cancer screening colonoscopy | – | – |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Single cohort of adults aged 45 and 75 years, representing an average-risk CRC population, undergoing routine colorectal cancer screening with colonoscopy in Argentina as standard of care.
Key inclusion criteria (2 listed)
- Men and women aged 45-75 years
- Indication of colorectal cancer screening colonoscopy by treating physician
Key exclusion criteria (6 listed)
- First-degree family history of CRC
- Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- Other malignancies within 5 years
- Known hereditary CRC syndromes (Lynch, FAP)
- Major trauma, surgery, transfusion in past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of colorectal cancer detection
Time frame: 18 months
Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer
Specificity of advanced neoplasia detection
Time frame: 36 months
Specificity of colorectal cancer detection
2 secondary outcomes
Accuracy of colorectal cancer precursor lesions detection
Time frame: 36 months
Predictive values
Time frame: 36 months
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 11 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Emanuel Campoy, PhD study director
CONICET-National Scientific and Technical Research Council
1 site 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 (CRC), run by Epiliquid Holding, Inc at 1 site in Argentina.
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 2 inclusion and 6 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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 Dr. Victoria Bocanegra, MD, PhD. (+5492616603254, victoria.bocanegra@epiliquid.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of colorectal cancer detection (time frame: 18 months). 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 11 Sep 2025.