Blood test for early detection of colorectal cancer
Smart Measurement of Circulating Tumor DNA: a Tumor-agnostic Computational Tool to Improve Colorectal Cancer Care
This study is testing a new blood test to see if it can find colorectal cancer early in people with Lynch Syndrome, who are at higher risk for this disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Leiden, South Holland and 1 other locations) |
| Trial ID | NCT06989814 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a blood test that can detect colorectal cancer at early stages, particularly in individuals with Lynch Syndrome, who are at higher risk for developing this type of cancer. Participants will provide an additional blood sample that will be analyzed for circulating tumor DNA (ctDNA) to identify molecular characteristics indicative of newly arising tumors. The study seeks to optimize the detection of ctDNA without prior tumor information, addressing the limitations of current surveillance methods. By improving early detection, the study hopes to enhance cancer prevention strategies for at-risk populations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are confirmed Lynch Syndrome carriers or have a microsatellite instability high tumor and have not yet received treatment for their cancer.
Not a fit: Patients who are under 18, unwilling to undergo blood sampling, or have already received treatment for their tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this blood test could significantly improve early detection and prevention of colorectal cancer in high-risk individuals.
How similar studies have performed: Other studies have shown promise in using ctDNA for cancer detection, but this approach is novel in the context of Lynch Syndrome and colorectal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (suspect) Lynch Syndrome carriers who: * Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor; * Are at least 18 years old; Have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet; * Have granted informed consent to participate in this study. Exclusion Criteria: (suspect) Lynch Syndrome carriers who: * Are unwilling to undergo extra blood sampling; * Are under the age of 18; * Have no newly diagnosed tumors at time of inclusion; * Have been treated for their tumor at time of inclusion; * Are not able to read or understand Dutch language or are mentally not capable.
Where this trial is running
Leiden, South Holland and 1 other locations
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Not_yet_recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Anja Wagner, Dr. — Erasmus Medical Center
- Study coordinator: Lotte van Leeuwen, BSc
- Email: l.vanleeuwen@erasmusmc.nl
- Phone: +31646245198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.