Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02280889

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Quality of Life Behavior Cicatrix Fibrosis Neoplasms Neoplasms by Histologic Type Nevi and Melanomas Nevus Pathologic Processes Pathological Conditions, Signs and Symptoms Social Behavior Stereotyping Stigmatization

Age range

9 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery

Zurich, 8008, Switzerland

Location status: Recruiting

Location contact

Kathrin Neuhaus, MD

CONTACT

[email protected]

+41442497466

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Primary outcomes

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

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

Secondary outcomes

  1. Change of experiences of stigmatization before and after surgery

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

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

  2. Satisfaction with the treatment

    Time frame: One year after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrin Neuhaus, MD

CONTACT

[email protected]

+41442497466

Markus Landolt, Prof

CONTACT

[email protected]

+41442496388

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study

Important dates

Study start
2013
Primary completion
2031
Study completion
2031
First posted
Nov 3, 2014
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.