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

This study is currently recruiting participants.
Verified August 2012 by Vanderbilt-Ingram Cancer Center
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01205815
First received: September 17, 2010
Last updated: August 24, 2012
Last verified: August 2012

September 17, 2010
August 24, 2012
June 2010
January 2020   (final data collection date for primary outcome measure)
Molecular changes in patients' melanoma tissue [ Time Frame: at 120 months ] [ Designated as safety issue: No ]
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.
To determine the molecular changes in the patient's melanoma tissue to aid patients and their treating physician when making treatment decisions [ Time Frame: At baseline ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01205815 on ClinicalTrials.gov Archive Site
Improve the time between ordering the test and results entry into medical records [ Time Frame: 120 months ] [ Designated as safety issue: No ]
To enhance the speed and detail of molecular mutation profiling of melanoma
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Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment
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The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.

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Observational
Time Perspective: Prospective
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Probability Sample

Patients with melanoma.

Melanoma
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
January 2020
January 2020   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: VICC Clinical Trials Information Program, RN 800-811-8480
United States
 
NCT01205815
VICC MEL 09109
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Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
Not Provided
Principal Investigator: Jeffrey Sosman, M.D. Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2012

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