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NCT01205815 Clinical Trial

Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment

Melanoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01205815
Other study ID # VICC MEL 09109
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 3, 2010
Est. completion date August 2025

Study information
Verified date February 2024
Source Vanderbilt-Ingram Cancer Center
Contact Vanderbilt-Ingram Service for Timely Access
Phone 800-811-8480
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date August 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Pathologically-proven diagnosis of melanoma. - Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible. Exclusion criteria - Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol. - Any patient unable or unwilling to provide consent.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Tissue and blood collection
Tissue will be obtained from a previous biopsy if available, or if unavailable, tissue will be collected from a scheduled biopsy. About3-4 teaspoons of blood will be collected.

Locations
Country Name City State
United States Vanderbitl-Ingram Cancer Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Molecular changes in patients' melanoma tissue Tissue is collected upon consent or upon receipt of parafin block, primary aim will be met when all tissues are collected and analyzed at conclusion of study. Intent is to aid patients and their treating physician when making treatment decisions. at 120 months
Secondary Improve the time between ordering the test and results entry into medical records To enhance the speed and detail of molecular mutation profiling of melanoma 120 months
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