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NCT04658303 · ClinicalTrials.gov registry record
Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
A clinical trial of Melanoma, sponsored by Yana Najjar.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT04658303: Recruiting study of Melanoma, sponsored by Yana Najjar.
NCT04658303 is a study of Melanoma that is actively recruiting participants, run by Yana Najjar. The registered enrollment target is 20 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04658303, a study of Melanoma, is actively recruiting participants, sponsored by Yana Najjar.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Immunometabolic profiling of individual microenvironments in ITMs (in-transit metastases) using flow cytometry via T cell subsets, markers of activation/exhaustion, and metabolic insufficiency (mitochondrial mass, glucose uptake capacity, and hypoxia by pimonidazole staining.
Conditions Studied
Interventions
- DRUG Pimonidazole
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2028-03-31 |
What NCT04658303 shows while recruiting
NCT04658303 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Pimonidazole is the first listed.
NCT04658303 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04658303 about?
NCT04658303 is a clinical study titled "Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma". 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 f...
What is the current status of trial NCT04658303?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2021-02-24. Estimated completion is 2028-03-31.
What conditions does trial NCT04658303 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04658303?
The interventions under investigation include: Pimonidazole (DRUG).
Who is sponsoring clinical trial NCT04658303?
This trial is sponsored by Yana Najjar, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04658303 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04658303's enrollment target sits among peer trials
20 229th of 266 higher than 36 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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