- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825470
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
- Liver Diseases
- Liver Transplantation
- Liver Neoplasms
- Gastrointestinal Stromal Tumors
- Metastasis
- Liver Metastases
- Liver Transplant; Complications
- Liver Cancer
- Liver Transplant Disorder
- Liver Carcinoma
- GIST, Malignant
- GIST
- Metastases
- Metastatic Liver Cancer
- Gastrointestinal Stromal Tumor of Stomach
- Gastrointestinal Stromal Tumor of Duodenum
- Gastrointestinal Stromal Tumor, Malignant
- Metastases to Liver
- Liver Mass
- Gastrointestinal Stromal Tumor of Rectum
- Gastrointestinal Stromal Tumor of Other Sites
- Gastrointestinal Stromal Tumor, Unspecified Site
- Gastrointestinal Stromal Tumor of Esophagus (Disorder)
- Gastrointestinal Stromal Tumor by AJCC V8 Stage
- Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
- Gastrointestinal Stromal Tumor of Small Intestine (Disorder)
- Gastrointestinal Stromal Tumor of Large Intestine (Disorder)
- Transplant Oncology
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
-
-
-
Murcia, Spain, 30120
- Felipe Alconchel
-
Contact:
- Felipe Alconchel, MD, PhD
- Phone Number: +34667524352
- Email: felipe.alconchel@carm.es
-
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
|
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.
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.
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
- Digestive System Diseases
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Neoplasms, Connective Tissue
- Liver Diseases
- Neoplasms
- Disease
- Carcinoma, Hepatocellular
- Colorectal Neoplasms
- Neoplasm Metastasis
- Gastrointestinal Stromal Tumors
- Liver Neoplasms
- Neoplasms, Second Primary
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.
Clinical Trials on Liver Diseases
-
King's College Hospital NHS TrustSamsung MedisonRecruitingHepatitis | Liver Fat | NAFLD | Fibrosis, Liver | Liver Disease Chronic | Liver Steatoses | NASH With FibrosisUnited Kingdom
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
-
Beijing Friendship HospitalUnknownNonalcoholic Fatty Liver Disease | Liver Steatosis | Liver FibrosisChina
-
Shiraz University of Medical SciencesCompletedFatty Liver | Fatty Liver, NonalcoholicIran, Islamic Republic of
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Medical College of WisconsinRecruiting
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Beijing Continent Pharmaceutical Co, Ltd.RecruitingAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
Taipei City HospitalThe One Biopharmaceutical Co., Ltd.CompletedNon-alcoholic Fatty Liver Disease | Liver Fibrosis | Liver InjuryTaiwan
-
Chuncheon Sacred Heart HospitalSuspendedChronic Liver Disease | Acute Derangement of Liver FunctionKorea, Republic of
Clinical Trials on Liver Transplantation
-
University of ZurichUnknownDeath | ComplicationSwitzerland
-
Austral University, ArgentinaCompleted
-
Rutgers, The State University of New JerseyRecruitingIntrahepatic Cholangiocarcinoma | Cholangiocarcinoma, IntrahepaticUnited States
-
Oslo University HospitalRecruiting
-
University Health Network, TorontoCompleted
-
University of FloridaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminatedLiver Cancer | Hepatobiliary Tract Adenomas and CarcinomasUnited States
-
Republican Specialized Scientific and Practical...RecruitingLiver Cirrhosis | Liver Transplant; ComplicationsUzbekistan
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityNot yet recruitingLiver Metastases | Liver Transplant; Complications | Liver Cancer | Transplant | Transplant; Failure, Liver | Transplant; Complication, Rejection | Transplant Dysfunction
-
Hospital Vall d'HebronRecruitingColorectal Cancer | Liver Metastases | Genetic ChangeSpain
-
University of LiegeUniversitaire Ziekenhuizen KU Leuven; University Hospital, Ghent; University... and other collaboratorsRecruitingHepatocellular CarcinomaBelgium