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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01205815
Recruitment Status : Recruiting
First Posted : September 21, 2010
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Douglas Johnson, Vanderbilt-Ingram Cancer Center

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

Condition or disease Intervention/treatment
Melanoma Other: Tissue and blood collection

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
Actual Study Start Date : June 3, 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Molecular changes in patients' melanoma tissue [ Time Frame: at 120 months ]
    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.

Secondary Outcome Measures :
  1. Improve the time between ordering the test and results entry into medical records [ Time Frame: 120 months ]
    To enhance the speed and detail of molecular mutation profiling of melanoma

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with melanoma.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01205815

Contact: VICC Clinical Trials Information Program, RN 800-811-8480

United States, Tennessee
Vanderbitl-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States
Contact: VICC Clinical Trials Information Program, M.D.    800-811-8480      
Principal Investigator: Jeffrey Sosman, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Principal Investigator: Jeffrey Sosman, M.D. Vanderbilt-Ingram Cancer Center

Additional Information:
Responsible Party: Douglas Johnson, Assistant Professor of Medicine, Vanderbilt-Ingram Cancer Center Identifier: NCT01205815     History of Changes
Other Study ID Numbers: VICC MEL 09109
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas