We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 November 2017 by Douglas Johnson, Vanderbilt-Ingram Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205815
First Posted: September 21, 2010
Last Update Posted: November 13, 2017
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.
Information provided by (Responsible Party):
Douglas Johnson, Vanderbilt-Ingram Cancer Center
  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: Observational Model: Other
Time Perspective: Prospective

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 2500
Actual Study Start Date: June 3, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Douglas Johnson, Assistant Professor of Medicine, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01205815     History of Changes
Other Study ID Numbers: VICC MEL 09109
First Submitted: September 17, 2010
First Posted: September 21, 2010
Last Update Posted: November 13, 2017
Last Verified: November 2017

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