Use of Ctdna in Patients With Gastrointestinal Tract Tumors

NCT ID: NCT06202131

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2028-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreas Cancer Colon Cancer Biliary Tract Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Sakvatore, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Policlinico Agostino Gemelli

Rome, Lazio, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lisa Salvatore, MD, PhD

Role: CONTACT

+390630156318

Giovanni Trovato, MD

Role: CONTACT

+390630156318

Facility Contacts

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Lisa Salvatore, MD, PhD

Role: primary

+390630156318

Giovanni Trovato, MD

Role: backup

+390630156318

Other Identifiers

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6151

Identifier Type: -

Identifier Source: org_study_id

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