Liver Transplantation for Unresectable GIST Liver Metastases (TRANSGIST)

February 24, 2022 updated by: Felipe Alconchel, Hospital Universitario Virgen de la Arrixaca

Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases

Liver Transplantation for Unresectable GIST Liver Metastases

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Felipe Alconchel
        • Contact:
        • Principal Investigator:
          • Juan Ángel Fernández-Hernández, MD, PhD
        • Principal Investigator:
          • Pablo Ramírez, MD, PhD
        • Principal Investigator:
          • Jerónimo Martínez, MD, PhD
        • Principal Investigator:
          • Francisco Sánchez-Bueno, MD, PhD
        • Principal Investigator:
          • Ricardo Robles, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GIST diagnosis (c-Kit, CD34, DOG-1)
  • Imatinib-sensitive mutation
  • Non-resectable liver metastases
  • Abscence of extrahepatic disease
  • Period greater than two years between primary tumor and metastases diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver Transplantation
Procedure: Liver Transplantation
Liver Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Through study completion, an average of 2 years
Survival
Through study completion, an average of 2 years
Graft Survival
Time Frame: Through study completion, an average of 2 years
Liver graft Survival
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse free survival
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Disease free survival
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRANSGIST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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