Back to resultsBone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma
Primary Purpose
Intraocular Melanoma
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
gene expression analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Sponsored by
About this trial
This is an observational trial for Intraocular Melanoma focused on measuring metastatic intraocular melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size
Eligibility Criteria
DISEASE CHARACTERISTICS:
Choroid melanoma
- Metastatic disease
- Planning to undergo general anesthesia
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No contraindications to the collection of a bone marrow sample
- No patient deprived of liberty or under trusteeship (including guardianship)
- No social or psychological situations that preclude the ability to give consent
PRIOR CONCURRENT THERAPY:
- Not specified
Sites / Locations
Outcomes
Primary Outcome Measures
Detection of micro-metastatic cells in 20 x 10^6 nucleated cells
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00897624
Brief Title
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma
Official Title
Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma
Study Type
Observational
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Curie
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help doctors find out the extent of disease.
PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma.
Detailed Description
OBJECTIVES:
Primary
Develop and validate a method of detecting tumor cells in the bone marrow and blood in patients with metastatic choroid melanoma.
OUTLINE: While patients are under general anesthesia for standard treatment of their disease, samples of bone marrow from the iliac crest and blood are collected. Samples are analyzed for the expression of tyrosinase and Melan-a via RT-PCR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma
Keywords
metastatic intraocular melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size
7. Study Design
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Detection of micro-metastatic cells in 20 x 10^6 nucleated cells
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Choroid melanoma
Metastatic disease
Planning to undergo general anesthesia
PATIENT CHARACTERISTICS:
Not pregnant or nursing
No contraindications to the collection of a bone marrow sample
No patient deprived of liberty or under trusteeship (including guardianship)
No social or psychological situations that preclude the ability to give consent
PRIOR CONCURRENT THERAPY:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre T. Dorval, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma
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