Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07153458

Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer

Led by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis ยท Updated on 2025-12-19

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

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Sponsors

A

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Lead Sponsor

U

University of Bari Aldo Moro

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to find new non-invasive biomarkers in the blood of patients with colorectal cancer (CRC). The goal is to develop a score that can predict the development of CRC. The study includes three groups: patients diagnosed with CRC undergoing surgery, individuals with a negative colonoscopy result, and those with adenoma with high-grade dysplasia, a precancerous condition. Participants in the first group will have their medical and family history reviewed and provide blood samples before and after surgery. Tissue samples leftover from surgery will also be collected for molecular analysis. Those in the second and third groups will undergo history reviews and blood sample collection after their colonoscopy, with enrollment based on their diagnosis. Blood samples will be analyzed for known tumor markers and potential new biomarkers using specialized lab techniques, including ATR-FTIR spectroscopy and protein characterization from extracellular vesicles. Participants will be assessed through medical history reviews, blood tests, and tissue analysis. Researchers will measure changes in serum biomarkers and the composition of biological samples from enrollment until about 20 days later. The study also involves storing samples in a biobank for further analysis. Safety monitoring and long-term follow-up are not detailed, but participants will be engaged mainly through these diagnostic and laboratory procedures during the study period.

CONDITIONS

Brief Title

Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing surgery at the U.O.C. of Surgery, with a diagnosis of colorectal cancer.
  • Subjects without colon disease.
  • Subjects with adenoma and high-grade dysplasia.
Not Eligible

You will not qualify if you...

  • Subjects with any other pathology not included in the inclusion criteria.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to enrollment day

Participants undergo diagnostic procedures such as colonoscopy or surgery as part of normal clinical practice, and relevant clinical history and blood samples are collected.

1 visit (in-person) for history review and blood sample collection

Monitoring

Duration - Approximately 20 days

Participants are observed with blood samples collected at enrollment and again about 20 days later to measure biomarkers related to colorectal cancer.

2 visits (in-person): one at enrollment and one follow-up visit about 20 days later

Trial Site Locations

Total: 1 location

1

Biobank Core Facility

Castellana Grotte, Italy, 70013

Actively Recruiting

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Research Team

P

Pasqua Letizia Pesole, Biologist

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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