Non-invasive blood biomarkers to detect colorectal cancer and high-grade adenomas
Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer
This study will test whether new non-invasive blood biomarkers can detect colorectal cancer or high-grade precancerous adenomas in people undergoing colonoscopy or colorectal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Castellana Grotte) |
| Trial ID | NCT07153458 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll three groups: patients with diagnosed colorectal cancer undergoing surgery, people with negative colonoscopy results, and people found to have high-grade adenomas. Participants will give medical history and provide blood at enrollment and at a follow-up visit, while leftover surgical tissue will be collected when available. Investigators will analyze serum and tissue for nucleic acids, proteins, and other macromolecules and combine signals to create a predictive score for colorectal cancer development. No experimental treatments are given; samples are collected alongside routine clinical care.
Who should consider this trial
Good fit: Adults who are having colonoscopy at the sponsoring center—either with a negative exam, with high-grade adenomas identified, or with confirmed colorectal cancer and scheduled for surgery—are ideal candidates.
Not a fit: People with other unrelated medical conditions or cancers not included in the study, or those unable to provide blood or tissue samples, are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this work could enable a simple blood test to detect colorectal cancer and high-risk adenomas earlier, potentially reducing reliance on invasive procedures.
How similar studies have performed: Related blood-based biomarker approaches (for example circulating tumor DNA, methylation markers, and protein panels) have shown promising but variable results, so this approach is supported by prior work but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AIM 1: Patients undergoing surgery at the U.O.C. of Surgery, with a diagnosis of CRC. * AIM 2: Subjects without colon disease. * AIM 3: Subjects with adenoma and high-grade dysplasia. Exclusion Criteria: * Subject with any other pathology not included in the inclusion criteria.
Where this trial is running
Castellana Grotte
- Biobank Core Facility — Castellana Grotte, Italy (Recruiting)
Study contacts
- Study coordinator: Pasqua Letizia Pesole, Biologist
- Email: letizia.pesole@irccsdebellis.it
- Phone: +390804994365
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.