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

NCT07153458 | Recruiting

• 1 other identifier: RC2025-26
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study in question is an observational study that aims to identify new non-invasive biomarkers present in the serum of patients with CRC and, subsequently, to create a score capable of predicting the development of CRC. It is an observational study with 3 enrollment arms: Arm 1: Patients undergoing surgery at the U.O.C. of Surgery, with a CRC diagnosis; Arm 2: Subjects with a negative result from the endoscopic examination; Arm 3: Subjects in whom the presence of an adenoma with high-grade dysplasia is found, a condition considered pre-cancerous.

Conditions

CRC (Colorectal Cancer); Adenoma Colon

Keywords

crc (colorectal cancer); Adenoma colon; Biomarkers; neoplasm

Outcome Measures

Primary Outcomes (1)

• Variation in serum biomarkers for CRC

  Changes in the concentration of potential serum CRC biomarkers in patients with established CRC pre- and post-surgery, patients with an adenoma with high-grade dysplasia, and subjects with no evidence of disease.

  From enrollment to the day of the visit after 20 days

Secondary Outcomes (1)

• Variation of macroconstituents

  From enrollment to the day of the visit after 20 days

Study Arms (3)

Patients undergoing surgery at the Department of Surgery, with a diagnosis of CRC;

Patients undergoing surgery at the Department of Surgery, with a diagnosis of CRC;

Subjects with a negative endoscopic examination result.

Subjects who attend our Institution's Department of Digestive Endoscopy for a colonoscopy performed for diagnostic purposes, with a negative endoscopic examination result.

Subjects with a diagnosis of adenoma with high-grade dysplasia, a condition considered pre-cancerous

Subjects who attend our Institution's Department of Digestive Endoscopy for a colonoscopy performed for diagnostic purposes, or patients undergoing a surgical procedure at the Department of Surgery, in whom the presence of an adenoma with high-grade dysplasia is found, a condition considered pre-cancerous.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort is comprised of patients with a diagnosis of CRC who underwent surgical intervention, and a cohort of subjects with high-grade dysplasia adenoma, which is considered a precancerous condition.

You may qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• University of Bari Aldo Moro: collaborator

Study Sites (1)

Biobank Core Facility

Castellana Grotte, 70013, Italy

RECRUITING

Related Publications (3)

• Martin-Garcia D, Garcia-Aranda M, Redondo M. Biomarker Identification through Proteomics in Colorectal Cancer. Int J Mol Sci. 2024 Feb 14;25(4):2283. doi: 10.3390/ijms25042283.

  PMID: 38396959 BACKGROUND

• Shah SC, Itzkowitz SH. Colorectal Cancer in Inflammatory Bowel Disease: Mechanisms and Management. Gastroenterology. 2022 Mar;162(3):715-730.e3. doi: 10.1053/j.gastro.2021.10.035. Epub 2021 Oct 29.

  PMID: 34757143 BACKGROUND

• Sninsky JA, Shore BM, Lupu GV, Crockett SD. Risk Factors for Colorectal Polyps and Cancer. Gastrointest Endosc Clin N Am. 2022 Apr;32(2):195-213. doi: 10.1016/j.giec.2021.12.008. Epub 2022 Feb 22.

  PMID: 35361331 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Pasqua Letizia Pesole, Biologist

CONTACT

+390804994365; letizia.pesole@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)