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Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 31, 2028 to Aug 31, 2029v9
  2. Primary and study completion dates: Mar 2027 to Mar 31, 2028 Collaborators expanded, about 1 wordv8 Show 1 more changeShow less
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Mar 2025 to Mar 2027v7
  4. Primary completion date: Mar 2023 to Mar 2025 Completion date: Mar 2024 to Mar 2025v6 Show 1 more changeShow less
    • Completion date: Mar 2024 to Mar 2025
  5. Lead sponsor: University of Pittsburgh to Yana Najjar Trial status: Suspended to Recruiting · Primary completion date: Dec 2021 to Mar 2023 · Completion date: Dec 2022 to Mar 2024 · 2 morev5 Show 5 more changesShow less
    • Trial status: Suspended to Recruiting
    • Primary completion date: Dec 2021 to Mar 2023
    • Completion date: Dec 2022 to Mar 2024
    • Interventions: Pimonidazole (Other) to Pimonidazole (Drug)
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Recruiting to Suspended Sponsor's reason: Study to resume after FDA and IRB review (IND application) Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2021 to Feb 24, 2021 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Feb 2021 to Feb 24, 2021
    • Site details revised
  3. Start date: Dec 2020 to Feb 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yana Najjar
6 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
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.
Trial Details
NCT Number NCT04658303
Lead Sponsor Yana Najjar
Collaborators: Hypoxyprobe
Conditions Melanoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov