Bone Marrow and Blood Samples From Patients With Metastat... | NCT00897624

Studies
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma

NCT00897624

Sponsor

Institut Curie

Status

Completed

Last Update Posted

May 13, 2011Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Intraocular Melanoma

Interventions

gene expression analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis

Countries

Not provided

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

May 2011

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

Nov 2007

Primary Completion Date

May 2011Actual

Completion Date

Not provided

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

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

May 12, 2011

Last Update Posted Date

May 13, 2011Estimated

Description Module

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.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic
reverse transcriptase-polymerase chain reaction	Genetic
laboratory biomarker analysis	Other

Measure	Description	Time Frame
Detection of micro-metastatic cells in 20 x 10^6 nucleated cells

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pierre T. Dorval, MD	Institut Curie	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000098943	Uveal Melanoma

Ancestor Terms

ID	Term
D008545	Melanoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020869	Gene Expression Profiling
D020133	Reverse Transcriptase Polymerase Chain Reaction

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
CLCC-IC-Micrometa-Melanome
CLCC-IC-2007-03
INCA-RECF0631