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RecruitingNCT02280889Updated Mar 4, 2026

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

An observational study in Quality of Life and Stigmatization, sponsored by University Children's Hospital, Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 9 Months to 16 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

Primary conditionNevusRegistry: StereotypingReclassifiedWhy we changed it
Registry
Stereotyping — the first condition term the registry derived for this study.
ClinicalTrials.gg
Nevus
Why
  1. Stereotyping is a broad heading, used only when no more specific condition is named.
  2. The study's title name Nevus.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Children's Hospital, Zurich · Observational

From the registry’s dates

  • Started May 2013; still recruiting 13 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
9 Months to 16 Years
Sex
All
01

Study summary

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.

Read the detailed description

All children with CMN that will have their nevus removed in our surgical department will be asked to participate. The investigators will send a package of questionnaires to evaluate quality of life and stigmatization before nevus surgery. One year after surgical therapy is finished (sometimes more then one session is necessary), the scar will be clinically evaluated and also another questionnaire package will be sent to evaluate the same parameters again. All parameters are checked for the patients and the families as well. Therefore self and proxy reports of the parents are asked. Moreover, for the patients this is done with interviews in case they are older than 7 years.

02

Conditions studied

  • Quality of Life
  • Stigmatization

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Keywords

  • quality of life
  • nevus or scar
  • stigmatization
  • scar
03

In context

Nevus Reclassified

47 studies on the registry are indexed under Nevus; 9 are open to participants now.

This study's planned enrollment of 100 is below the median of 145 across 28 observational studies indexed under Nevus.

Browse Nevus studies →

Lead sponsor

University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.

Compared within Nevus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stereotyping. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
9 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with CMN of at least 2 square centimeter (projected adult size) that are scheduled for surgical removal of the CMN at our tertiary center for pediatric surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with a congenital melanocytic nevi of at least 2 cm2 that will be removed surgically
  • age between 9 months and 16 years

Exclusion criteria

Exclusion Criteria:

  • mental retardation of the child
  • insufficient knowledge of the German language of both parents
  • severe comorbidities
  • previous therapies done for the CMN (dermabrasion, surgery, laser)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change of Quality of Life of affected children before and after surgery

    Quality of life with the CMN and in comparison with the scar after nevus excision is measured using validated age-related questionnaires respectively one-to one interviews

    Time frame: Before surgery, up to 90 days after screening and one year after surgery

Secondary outcomes

  1. Change of experiences of stigmatization before and after surgery

    Stigmatization experiences of patients and parents before CMN surgery in comparison with after nevus excision are measured using standardized and validated questionnaires

    Time frame: Before surgery, up to 90 days after screening and one year after surgery

  2. Satisfaction with the treatment

    Satisfaction with the treatment is evaluated one year after the last surgical step using open questions with rating scales

    Time frame: One year after surgery

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02280889
Lead sponsor
University Children's Hospital, Zurich
Responsible party
Sponsor
First posted
Nov 3, 2014
Start date
May 2013
Primary completion
Dec 2031 (estimated)
Completion
Dec 2031 (estimated)
Last update
Mar 4, 2026

Study contacts

Kathrin Neuhaus, MD
Contact
kathrin.neuhaus@kispi.uzh.ch
+41442497466
Markus Landolt, Prof
Contact
markus.landolt@kispi.uzh.ch
+41442496388
Kathrin Neuhaus, MD
principal investigator · University Children's Hospital, Zurich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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