Non-invasive blood biomarkers to detect colorectal cancer and high-grade adenomas
Official title: Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer
Run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · NCT07153458 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Castellana Grotte) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2027 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07153458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Biobank Core Facility
Castellana Grotte, Italy Recruiting
Study contacts
- Study coordinator: Pasqua Letizia Pesole, Biologist
- Email: letizia.pesole@irccsdebellis.it
- Phone: +390804994365
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Stool-based gene methylation test for early colorectal cancer and adenoma detection
This project will try a stool-based DNA methylation test to see if it can detect colorectal cancer and adenomas in people aged 40 and older.
-
Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
-
ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients
This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.
-
HDM2017 combination therapy in advanced colorectal cancer
A small and mid-size study tests HDM2017 with standard chemotherapy and targeted drugs to see if it’s safe and may help people with unresectable or metastatic colorectal cancer.
-
Retlirafusp alfa with bevacizumab and chemotherapy (with or without short radiotherapy) for colorectal cancer liver metastases
This study tests whether adding retlirafusp alfa to bevacizumab and chemotherapy, with or without short-course radiotherapy, can help patients with advanced colorectal cancer that has spread to the liver.
-
SHR-1701 with short-course radiotherapy and CAPOX before surgery for locally advanced rectal cancer
This will test whether adding the drug SHR-1701 to short-course radiotherapy plus CAPOX before surgery helps people with locally advanced rectal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.