Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract

Colon Cancer Clinical Trial

— ctDNA-GI  

Official title:

Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202131
• Other study ID #: 6151
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 1, 2028

Study information

• Verified date: December 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Lisa Salvatore, MD, PhD
• Phone: +390630156318
• Email: lisa.salvatore[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Colon Cancer
• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Italy	Policlinico Agostino Gemelli	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mOS	The primary endpoint of the study is to evaluate the probability of overall survival (mOS) in relation to the expression of specific molecular markers present in the plasma/faeces of patients.	3 years