RecruitingNot Applicable

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

Switzerland100 participantsStarted 2013-05

Plain-language 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.

Who can participate

Age range

9 Months – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT02280889

SponsorUniversity Children's Hospital, Zurich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-12

Contact for this trial

Kathrin Neuhaus, MD

+41442497466 kathrin.neuhaus@kispi.uzh.ch

View on ClinicalTrials.gov More Quality of Life trials