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

Sponsor
Vanderbilt-Ingram Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT01205815
Collaborator
(none)
2,000
1
157.9
12.7

Study Details

Study Description

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 Phase
  • Other: Tissue and blood collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Prospective
Actual Study Start Date :
Jun 3, 2010
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Molecular changes in patients' melanoma tissue [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 [120 months]

    To enhance the speed and detail of molecular mutation profiling of melanoma

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 Vanderbitl-Ingram Cancer Center Nashville Tennessee United States

Sponsors and Collaborators

  • Vanderbilt-Ingram Cancer Center

Investigators

  • Principal Investigator: Douglas Johnson, M.D., Vanderbilt-Ingram Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Douglas Johnson, Assistant Professor of Medicine, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01205815
Other Study ID Numbers:
  • VICC MEL 09109
First Posted:
Sep 21, 2010
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022