Liver Transplantation and Uveal Malignant Melanoma | NCT01311466

Studies
Liver Transplantation and Uveal Malignant Melanoma

NCT01311466

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Oct 23, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Uveal Malignant Melanoma

Interventions

Liver transplantation

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Mar 7, 2011

First Submission Date that Met QC Criteria

Mar 7, 2011

First Posted Date

Mar 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2017

Last Update Posted Date

Oct 23, 2017Actual

Description Module

Brief Summary

Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver transplantation	Experimental	The liver transplantation will be performed as described by the standard protocol, Liver Transplantation Protocol (Version 2006) at the Oslo University Hospital	Procedure: Liver transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver transplantation	Procedure		Liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Over all survival	Patient survival after livertransplantation	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uveal malignant melanoma
Liver metastases
ECOG 0-1

Exclusion Criteria:

Extra hepatic disease
Previous other malignancy
Previous organ transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Svein Dueland, MD, PhD	Oslo University Hospital, Radium hospitalet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		N0310	Norway

Intervention Browse Module

MeSH Terms

ID	Term
D016031	Liver Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided