Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma

Intraocular Melanoma Clinical Trial

Official title:

Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897624
• Other study ID #: CDR0000633500
• Secondary ID: CLCC-IC-Micromet
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 12, 2011
• Start date: November 2007

Study information

• Verified date: May 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Uveal Neoplasms

Intervention

Genetic:
• gene expression analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of micro-metastatic cells in 20 x 10^6 nucleated cells			No