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

September 15, 2025 updated by: Douglas Johnson, Vanderbilt-Ingram Cancer Center
The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vanderbilt-Ingram Service for Timely Access
  • Phone Number: 800-811-8480

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States
        • Recruiting
        • Vanderbitl-Ingram Cancer Center
        • Contact:
          • Vanderbilt-Ingram Service for Timely Access
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Douglas Johnson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with melanoma.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2010

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimated)

September 21, 2010

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC MEL 09109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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