Use of Ctdna in Patients With Gastrointestinal Tract Tumors (ctdna-GI)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Biliary Tract Cancer; Colon Cancer; Pancreas Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06202131

6151

Details and patient eligibility

About

This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.

Full description

This is a a prospective observational single-center study; it is a spontaneous study, not sponsored by pharmaceutical companies, and does not involve the use of experimental drugs. The study involves a collection of data, carried out while protecting the anonymity and personal information of individual patients suffering from neoplasms of the gastrointestinal tract, the execution of peripheral blood samples and the collection of faecal material at pre-determined times -points. Circulating biomarkers (as ctDNA) will be evaluated in these samples, in order to optimize both the diagnostic and therapeutic processes of patients with tumors of the gastrointestinal tract.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• PS ECOG <2;
• Histological diagnosis of gastrointestinal cancer: esophageal, gastric, intestinal, pancreatic, biliary tract neoplasms;
• Radiological evidence of resectable/locally advanced/metastatic disease on the date of signing the written informed consent;
• Adequate organ and function;
• Availability of tumor histological material.

Exclusion criteria

• No histological diagnosis of neoplasia of the gastrointestinal tract.
• No written informed consent.