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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049010
• Other study ID #: CALGB-500105
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: N/A
• First received: November 12, 2002
• Last updated: June 30, 2016
• Start date: September 2002
• Est. completion date: October 2009

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: October 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• comparative genomic hybridization

• cytogenetic analysis

• fluorescence in situ hybridization

Other:
• immunohistochemistry staining method

Locations

Country	Name	City	State
United States	Mountainview Medical	Berlin	Vermont
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Iowa Blood and Cancer Care	Cedar Rapids	Iowa
United States	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Danville Regional Medical Center	Danville	Virginia
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	Capital Region Cancer Center	Jefferson City	Missouri
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Fairview University Medical Center - University Campus	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Miriam Hospital at Lifespan	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York
United States	Community General Hospital of Greater Syracuse	Syracuse	New York
United States	Wilson Medical Center	Wilson	North Carolina
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	Commonwealth Hematology-Oncology P.C. - Worcester	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival		Up to 3.5 years	No