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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
History of Changes
  Purpose

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


Condition Intervention
Melanoma
 Other: Tissue and blood collection

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: June 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with melanoma.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205815

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

Locations
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
Investigators
Principal Investigator: Jeffrey Sosman, M.D. Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jeffrey A. Sosman, MD, Professor of Medicine; Director, Melanoma and Tumor Immunotherapy Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01205815     History of Changes
Other Study ID Numbers: VICC MEL 09109
Study First Received: September 17, 2010
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013