Clincosm LogoSign in Get a demo

A Storage Facility for Tissues Obtained From Patients With Malignant Melanoma

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04567706
Collaborator
(none)
1,000
Enrollment
1
Location
127.8
Anticipated Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. New prognostic markers in malignant melanoma [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: William E Carson, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
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
First Posted:
Sep 28, 2020
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Melanoma

Study Results

No Results Posted as of Oct 25, 2021