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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Patients undergoing surgery at the Department of Surgery, with a diagnosis of CRC;
Group B: Subjects with a negative endoscopic examination result.
Group C: Subjects with a diagnosis of adenoma with high-grade dysplasia, a condition considered pre-cancerous

Trial outcomes

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.

Time frame
From enrollment to the day of the visit after 20 days

Secondary outcomes

1

Variation of macroconstituents

Variation in the macromolecule composition of biological samples.

Time frame
From enrollment to the day of the visit after 20 days

Other outcomes

Sponsors and contacts

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