NCT00049010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

3.5 years

First QC Date

November 12, 2002

Last Update Submit

June 30, 2016

Conditions

Melanoma (Skin)

Keywords

stage I melanomastage II melanoma

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival

    Up to 3.5 years

Study Arms (1)

Group 1

EXPERIMENTAL

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.

Genetic: comparative genomic hybridizationGenetic: cytogenetic analysisGenetic: fluorescence in situ hybridizationOther: immunohistochemistry staining method

Interventions

comparative genomic hybridizationGENETIC
Group 1
cytogenetic analysisGENETIC
Group 1
fluorescence in situ hybridizationGENETIC
Group 1
immunohistochemistry staining methodOTHER
Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (27)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Iowa Blood and Cancer Care

Cedar Rapids, Iowa, 52402, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Commonwealth Hematology-Oncology P.C. - Worcester

Worcester, Massachusetts, 01605, United States

Location

Fairview University Medical Center - University Campus

Minneapolis, Minnesota, 55455, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Capital Region Cancer Center

Jefferson City, Missouri, 65101, United States

Location

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, 03431, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, 13057, United States

Location

Community General Hospital of Greater Syracuse

Syracuse, New York, 13215, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital at Lifespan

Providence, Rhode Island, 02906, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Comparative Genomic HybridizationCytogenetic AnalysisIn Situ Hybridization, FluorescenceImmunohistochemistry

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMolecular Diagnostic TechniquesNucleic Acid HybridizationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesHistological TechniquesHistocytochemistryImmunologic Techniques

Study Officials

  • F. Stephen Hodi, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

March 1, 2006

Study Completion

October 1, 2009

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

US(27)