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Quality of Life and Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study Identification, Study Status, Oversightv14
  2. Site details revisedv13
  3. 3 versions Re-verified since Jun 1, 2022, no change to tracked fieldsv10-v12
  4. Primary and study completion dates: Dec 2024 to Dec 2031
    • Enrollment target: 80 to 100
    v9
  5. Primary and study completion dates: Oct 2020 to Dec 2024
    • Start date: Oct 2013 to May 2013
    • Site contact updated
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. 4 versions Re-verified since Jun 17, 2015, no change to tracked fieldsv4-v7
  2. Primary and study completion dates: Oct 2018 to Oct 2020v3
  3. Secondary endpoints: details revised at 1 of 2 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Congenital melanocytic nevi (CMN) are a quite common congenital disorder. Over years, surgical excision was proposed to the patients because transformation into a malignant skin tumor (melanoma) was feared. Recent data proof that the risk for malignancy was overestimated. Nowadays still a lot of patients express their wish for surgical removal out of aesthetic reasons and psychological impacts. Many patients and families experience stigmatization because of the nevus. To proof a medical indication for surgical removal the investigators want to evaluate the quality of life and stigmatization before and after nevus surgery.
Trial Details
NCT Number NCT02280889
Lead Sponsor University Children's Hospital, Zurich
Conditions
(from sponsor)		 Quality of Life, Stigmatization
Related terms Cicatrix, Nevus, Stereotyping
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov