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Liver Transplantation for Unresectable GIST Liver Metastases (TRANSGIST)

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ClinicalTrials.gov Identifier: NCT04825470
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Felipe Alconchel, Hospital Universitario Virgen de la Arrixaca

Tracking Information
First Submitted Date  ICMJE March 23, 2021
First Posted Date  ICMJE April 1, 2021
Last Update Posted Date March 11, 2022
Estimated Study Start Date  ICMJE May 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • Overall Survival [ Time Frame: Through study completion, an average of 2 years ]
    Survival
  • Graft Survival [ Time Frame: Through study completion, an average of 2 years ]
    Liver graft Survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • Relapse free survival [ Time Frame: Through study completion, an average of 2 years ]
  • Disease free survival [ Time Frame: Through study completion, an average of 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Transplantation for Unresectable GIST Liver Metastases
Official Title  ICMJE Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases
Brief Summary Liver Transplantation for Unresectable GIST Liver Metastases
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Diseases
  • Liver Cancer
  • Liver Metastases
  • Liver Neoplasms
  • Liver Mass
  • Liver Carcinoma
  • Liver Transplant; Complications
  • Liver Transplant Disorder
  • GIST
  • GIST, Malignant
  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Stromal Tumor of Duodenum
  • Gastrointestinal Stromal Tumor of Rectum
  • Gastrointestinal Stromal Tumor of Other Sites
  • Gastrointestinal Stromal Tumor, Unspecified Site
  • Gastrointestinal Stromal Tumor of Stomach
  • Gastrointestinal Stromal Tumor of Esophagus (Disorder)
  • Gastrointestinal Stromal Tumor by AJCC V8 Stage
  • Gastrointestinal Stromal Tumor, Malignant
  • Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
  • Gastrointestinal Stromal Tumor of Small Intestine (Disorder)
  • Gastrointestinal Stromal Tumor of Large Intestine (Disorder)
  • Metastases to Liver
  • Metastatic Liver Cancer
  • Metastasis
  • Metastases
  • Liver Transplantation
  • Transplant Oncology
Intervention  ICMJE Procedure: Liver Transplantation
Liver Transplantation
Study Arms  ICMJE Experimental: Liver Transplantation
Intervention: Procedure: Liver Transplantation
Publications * Fernandez JA, Alconchel F, Gomez B, Martinez J, Ramirez P. Unresectable GIST liver metastases and liver transplantation: A review and theoretical basis for a new indication. Int J Surg. 2021 Oct;94:106126. doi: 10.1016/j.ijsu.2021.106126. Epub 2021 Sep 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2022)		 50
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2021)		 70
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04825470
Other Study ID Numbers  ICMJE TRANSGIST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Felipe Alconchel, Hospital Universitario Virgen de la Arrixaca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospital Universitario Virgen de la Arrixaca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Virgen de la Arrixaca
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP