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NCT04567706 Clinical Trial

A Storage Facility for Tissues Obtained From Patients With Malignant Melanoma

Melanoma Clinical Trial

Official title:
Analysis of the Tumor Microenvironment and Immune Response in Malignant Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04567706
Other study ID # OSU-13114
Secondary ID NCI-2020-06536
Status Recruiting
Phase
First received
Last updated
Start date May 7, 2013
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. The purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. Storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease.

Description:

PRIMARY OBJECTIVE: I. Facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma. OUTLINE: Patients undergo collection of blood samples at the time of the initial diagnostic work-up, and possibly prior to the initiation of surgery, chemotherapy, immunotherapy, or radiation therapy, at tumor progression or recurrence, and annually during routine follow-up (no more than 4 blood draws per year). Patients may also undergo collection of tissue sample during standard of care surgical or radiologic procedures. Healthy individuals undergo collection of blood samples up to 4 times over 1 year.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient with malignant melanoma or personal history of melanoma - Normal donors - Informed consent can be obtained - Patients with any stage of malignant melanoma Exclusion Criteria: - Incarcerated individuals will be excluded from this protocol

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue samples

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary New prognostic markers in malignant melanoma Facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma. . Draws conducted at baseline prior to immune therapy, four weeks after draw 1 and prior to the third cycle. Up to 3 months
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