Actively Recruiting
Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
Led by Yana Najjar · Updated on 2025-05-08
20
Participants Needed
1
Research Sites
370 weeks
Total Duration
On this page
Sponsors
Y
Yana Najjar
Lead Sponsor
H
Hypoxyprobe
Collaborating Sponsor
AI-Summary
What this Trial Is About
Melanoma in-transit metastases (ITMs) continue to represent a therapeutic dilemma, in that no standard method of treatment has been uniformly adopted. The complexity and heterogeneity of patient and disease characteristics, including the location and number of ITMs presents a barrier to a one size fits all treatment approach. Treatment of patients with limited regional disease remains challenging. Patients are typically treated with a combination of surgery, regional therapy, systemic therapy. Data on the management of ITMs is limited, even with the availability of immunotherapy (IMT). This study will use the unique etiology of ITMs to facilitate the understanding of how individual lesions metabolically and immunologically evolve as they move away from the primary tumor site. It is hypothesize that as ITMs move away from the primary melanoma site each will harbor progressively hypermetabolic tumor cells and a harsher microenvironment.
CONDITIONS
Official Title
Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older on the day of signing informed consent.
- Have a histological diagnosis of melanoma and at least two in-transit lesions at distinct distances from the primary site, or be diagnosed with in-transit disease by a treating melanoma oncologist.
- Have cutaneous, mucosal, or uveal melanoma.
- Be either treatment-naive or currently receiving treatment.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days before pimonidazole administration.
You will not qualify if you...
- In-transit disease that cannot be biopsied as determined by the treating physician.
- Known chronic immunosuppression, including use of biologic agents like Remicade, mycophenolate, methotrexate, or prednisone over 20 mg daily.
- Known infection with HIV, Hepatitis B, or Hepatitis C.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
A
Amy Rose, RN, BSN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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