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NCT00588198 Clinical Trial

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

Melanoma Clinical Trial

Official title:
Study of Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00588198
Other study ID # 91-125
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1991
Est. completion date September 2009

Study information
Verified date September 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 754
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years
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