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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00049010
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE November 12, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 1, 2016
Study Start Date  ICMJE September 2002
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
Relapse-free survival [ Time Frame: Up to 3.5 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
Official Title  ICMJE Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Diagnostic
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Genetic: comparative genomic hybridization
  • Genetic: cytogenetic analysis
  • Genetic: fluorescence in situ hybridization
  • Other: immunohistochemistry staining method
Study Arms  ICMJE Experimental: Group 1

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.

Interventions:
  • Genetic: comparative genomic hybridization
  • Genetic: cytogenetic analysis
  • Genetic: fluorescence in situ hybridization
  • Other: immunohistochemistry staining method
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2011)
314
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00049010
Other Study ID Numbers  ICMJE CALGB-500105
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-500105
CDR0000257230 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: F. Stephen Hodi, MD Dana-Farber Cancer Institute
PRS Account Alliance for Clinical Trials in Oncology
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP