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Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897624
First Posted: May 12, 2009
Last Update Posted: May 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Intraocular Melanoma Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Detection of micro-metastatic cells in 20 x 10^6 nucleated cells

Estimated Enrollment: 15
Study Start Date: November 2007
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897624


Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Pierre T. Dorval, MD Institut Curie
  More Information

ClinicalTrials.gov Identifier: NCT00897624     History of Changes
Other Study ID Numbers: CDR0000633500
CLCC-IC-Micrometa-Melanome
CLCC-IC-2007-03
INCA-RECF0631
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: May 13, 2011
Last Verified: May 2011

Keywords provided by National Cancer Institute (NCI):
metastatic intraocular melanoma
ciliary body and choroid melanoma, medium/large size
ciliary body and choroid melanoma, small size

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases