Use of Ctdna in Patients With Gastrointestinal Tract Tumors

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06202131

Acronym

ctdna-GI

Enrollment

100

Registered

2024-01-11

Start date

2023-11-01

Completion date

2028-11-01

Last updated

2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer, Colon Cancer, Pancreas Cancer

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
mOS	3 years	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.

Countries

Italy

Contacts

Primary ContactLisa Salvatore, MD, PhD

lisa.salvatore@policlinicogemelli.it+390630156318

Backup ContactGiovanni Trovato, MD

giovanni.trovato@guest.policlinicogemelli.it+390630156318

Outcome results