Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280889
Recruitment Status : Recruiting
First Posted : November 2, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief 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.

Condition or disease
Quality of Life Stigmatization

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Experience of Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision: a Prospective Study
Study Start Date : October 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Months to 16 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280889


Contacts
Layout table for location contacts
Contact: Kathrin Neuhaus, MD 0041442668154 kathrin.neuhaus@kispi.uzh.ch
Contact: Markus Landolt 0442667111 markus.landolt@kispi.uzh.ch

Locations
Layout table for location information
Switzerland
University Children`s Hospital Zurich, Division of Pediatric Plastic and reconstructive Surgery Recruiting
Zurich, Switzerland, 8032
Contact: Kathrin Neuhaus, MD    0043442667111    kathrin.neuhaus@kispi.uzh.ch   
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Layout table for investigator information
Principal Investigator: Kathrin Neuhaus, MD University Children`s Hospital Zurich
Layout table for additonal information
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02280889    
Other Study ID Numbers: 2013-0242
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Keywords provided by University Children's Hospital, Zurich:
quality of life
nevus or scar
stigmatization
scar
Additional relevant MeSH terms:
Layout table for MeSH terms
Nevus
Nevus, Pigmented
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms