Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00049010

Enrollment

314

Registered

2003-01-27

Start date

2002-09-30

Completion date

2009-10-31

Last updated

2016-07-01

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

Conditions

Melanoma (Skin)

Keywords

stage I melanoma, stage II melanoma

Brief summary

RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer. PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.

Detailed description

OBJECTIVES: * Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma. * Correlate melastatin expression prospectively with event-free survival of these patients. OUTLINE: This is a multicenter study. Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy. Patients are followed every 4 months for 3.5 years. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

Interventions

GENETICcomparative genomic hybridization

GENETICcytogenetic analysis

GENETICfluorescence in situ hybridization

OTHERimmunohistochemistry staining method

Study design

Allocation

NON_RANDOMIZED

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted. 2. Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma. 3. ≥18 years of age 4. Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration. 5. No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma. 6. Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.

Design outcomes

Primary

Measure	Time frame
Relapse-free survival	Up to 3.5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026