Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More CRC (Colorectal Cancer) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Academic / other
Drugs / interventionsradiation
Locations1 site (Castellana Grotte)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 1, 2026
Study endsDecember 1, 2027
Registry record updatedDecember 19, 2025
Trial IDNCT07153458 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.