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A Storage Facility for Tissues Obtained From Patients With Malignant Melanoma

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.
 
ClinicalTrials.gov Identifier: NCT04567706
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Carson, Ohio State University Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Melanoma Procedure: Biospecimen Collection

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Tumor Microenvironment and Immune Response in Malignant Melanoma
Actual Study Start Date : May 7, 2013
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
Ancillary-correlative (biospecimen collection)
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.
Procedure: Biospecimen Collection
Undergo collection of blood and tissue samples




Primary Outcome Measures :
  1. New prognostic markers in malignant melanoma [ Time Frame: Up to 3 months ]
    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.


Biospecimen Retention:   Samples With DNA
Blood and tissue


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are being evaluated or treated for malignant melanoma by members of the departments of Surgical Oncology, Medical Oncology, and Radiation Oncology and normal controls
Criteria

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

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): NCT04567706


Contacts
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Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: William E. Carson, MD    614-293-6306      
Principal Investigator: William E. Carson, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William E Carson, MD Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: William Carson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04567706    
Other Study ID Numbers: OSU-13114
NCI-2020-06536 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU-13114 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
P01CA095426 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas