Liver Transplantation and Uveal Malignant Melanoma

This study is currently recruiting participants.

Verified October 2012 by Oslo University Hospital

Sponsor:

Information provided by:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01311466

First received: March 7, 2011

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 7, 2011
Last Updated Date	October 11, 2012
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	January 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 7, 2011)	Over all survival
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01311466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Liver Transplantation and Uveal Malignant Melanoma
Official Title ^ICMJE	Not Provided
Brief Summary	Patients with uveal malignatnt melanoma with liver metastases have a dismal prognosis with a median survival of less than 12 months. There is noe established treatment showing increased overall survival. In this study we will determin if liver transplantation will result in long term survival in patients with liver only metastases from uveal malignant melanoma.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uveal Malignant Melanoma
Intervention ^ICMJE	Procedure: Liver transplantation Other Name: Liver transplantation
Study Arm (s)	Experimental: Liver transplantation Intervention: Procedure: Liver transplantation
Publications *	Not Provided
* 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	Recruiting
Estimated Enrollment ^ICMJE	6
Estimated Completion Date	January 2018
Estimated Primary Completion Date	January 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria:Uveal malignant melanoma, liver only metastases, ECOG 0-1 - Exclusion Criteria:Extra hepatic disease, previous other maligency, previous organ transplantation -
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01311466
Other Study ID Numbers ^ICMJE	S-06408
Has Data Monitoring Committee	Not Provided
Responsible Party	Svein Dueland, Oslo University Hospital
Study Sponsor ^ICMJE	Oslo University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Oslo University Hospital
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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