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Evaluation of Hypoxia in Primary Melanoma

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 31, 2027 to Mar 31, 2029v3
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 31, 2025 to Apr 9, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 31, 2025 to Apr 9, 2025
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
When controlling for tumor present in the Sentinel lymph node (SLN), intranodal hypoxia, as measured by Carbonic Anhydrase IX (CAIX IHC), is associated with worse PFS. This suggests that melanoma tumors may be utilizing deregulated metabolism as a means of propagating themselves to the next station of metastasis. This study aims to prospectively validate previous findings. Patients who are to undergo WLE and SLNB per standard of care (SOC) will be evaluable. It is hypothesized that SLN(s) with increased hypoxia, as measured by pimonidazole staining, will be associated with worse Progression-free Survival (PFS).
Trial Details
NCT Number NCT06831071
Lead Sponsor Yana Najjar
Collaborators: Hypoxyprobe
Conditions Melanoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov