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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Melanoma (Skin)

Treatments: Other: immunohistochemistry staining method; Genetic: fluorescence in situ hybridization; Genetic: cytogenetic analysis; Genetic: comparative genomic hybridization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00049010

CDR0000257230 (Registry Identifier)

CALGB-500105

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

314 participants in 1 patient group

Group 1

Experimental group

Description:

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.

Treatment:

Genetic: comparative genomic hybridization

Other: immunohistochemistry staining method

Genetic: fluorescence in situ hybridization

Genetic: cytogenetic analysis