NCT04658303 · ClinicalTrials.gov record · last posted 2026-06-11
Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
StatusRecruiting
PhaseNot specified
Started2021-02-24
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from the ClinicalTrials.gov record
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.
Amendment record
8 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 8 times since 2020-12-01; most recent amendment 2026-06-08. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2022-02-11
Status change Suspended→Recruitingv4
2021-04-12
Status change Recruiting→Suspendedv3
2021-02-24
Status change Not Yet Recruiting→Recruitingv2
| NCT Number |
NCT04658303 |
| Lead Sponsor |
Yana Najjar
Collaborators: Hypoxyprobe |
| Conditions |
Melanoma |
| Enrollment |
20 participants |
| Start Date |
2021-02-24 |
| Primary Completion |
2029-08-31 (estimated) |
| Study Completion |
2029-08-31 (estimated) |
| Updated on ClinicalTrials.gov |
2026-06-11 |