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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00588198

Enrollment

754

Registered

2008-01-08

Start date

1991-10-31

Completion date

2009-09-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

histologically confirmed melanoma of any site

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results