About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Subject with any other pathology not included in the inclusion criteria.
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Variation of macroconstituents
Variation in the macromolecule composition of biological samples.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor
University of Bari Aldo Moro
Collaborator