Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588198

Purpose

The purpose of this study is to determine if tumor cells can be detected in the peripheral blood and/or bone marrow of patients with melanoma.

Condition
Melanoma

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Study of Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Assess the sensitivity of RT-PCR to detect evidence of melanoma cells in bone marrow and/or peripheral blood and estimate sensitivity separately for each of the different stage groupings for melanoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Bone marrow and blood

Estimated Enrollment:	950
Study Start Date:	October 1991
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Melanoma patients

Detailed Description:

Patients with melanoma can succumb to subclinical metastatic disease, not detectable at presentation by conventional physical examination, hematologic and biochemical screening, or radiologic evaluation. More intensive radiologic evaluation with CT or radioisotope scanning has not proven to be useful. What may be useful is a more sensitive method of staging melanoma patients at presentation, specifically evaluating them for subclinical systemic disease.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Melanoma Patients seen at Memorial Sloan-Kettering Cancer Center (MSK)

Criteria

Inclusion Criteria:

MSK Patients with histologically confirmed melanoma of any site and at least one of the following:

Primary tumor > 4.0 mm thick (AJCC Stage IIB)
Clinically or histologically positive regional nodes (AJCC Stage III)
Any in transit disease (AJCC Stage III)
Any systemic metastases (AJCC Stage IV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588198

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Danile Coit, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Robert Coit, MD )
Study ID Numbers:	91-125
Study First Received:	December 24, 2007
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00588198
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

histologically confirmed melanoma of any site

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes

Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009