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NCT06202131 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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