Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897624
First received: May 9, 2009
Last updated: May 12, 2011
Last verified: May 2011
  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 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897624

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897624     History of Changes
Other Study ID Numbers: CDR0000633500, CLCC-IC-Micrometa-Melanome, CLCC-IC-2007-03, INCA-RECF0631
Study First Received: May 9, 2009
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 24, 2014