Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 10:49 AM
Study NCT ID:
NCT04567706
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2020-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Storage Facility for Tissues Obtained From Patients With Malignant Melanoma
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Analysis of the Tumor Microenvironment and Immune Response in Malignant Melanoma
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-06536 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |