Use of Ctdna in Patients With Gastrointestinal Tract Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreas Cancer, Colon Cancer, Biliary Tract Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Single-center Study About the Use of Ctdna in the Management of Patients With Tumors of the Gastrointestinal Tract
Overview
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.
Primary outcome measures
- mOS [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Policlinico Agostino Gemelli — Rome
Identifiers
NCT: NCT06202131 · 6151