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


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Not Enrolling
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Melanoma

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Trial Information

Study of Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in 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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Danile Coit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

91-125

NCT ID:

NCT00588198

Start Date:

October 1991

Completion Date:

September 2009

Related Keywords:

  • Melanoma
  • histologically confirmed melanoma of any site
  • Melanoma
  • Neoplasm Metastasis

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021