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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588198
First received: December 24, 2007
Last updated: October 1, 2009
Last verified: October 2009

December 24, 2007
October 1, 2009
October 1991
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00588198 on ClinicalTrials.gov Archive Site
Not Provided
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Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma
Study of Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Bone marrow and blood

Non-Probability Sample

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

Melanoma
Not Provided
1
Melanoma patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
754
September 2009
September 2009   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588198
91-125
No
Robert Coit, MD, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Danile Coit, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP