Melanocytic Nevi in Children Under Chemotherapy

Nevus, Pigmented Clinical Trial

Official title:

Melanocytic-Nevi-Counts During Chemotherapy of Children With Malignancies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600431
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: January 24, 2008
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

Changes in nevus count in 16 children (8m, 8f) aged between 2 and 17 years (median:8 years) suffering from different malignancies were examined every three months during a one-year period after starting chemotherapy. An age and sex matched control group underwent the same skin examinations.At the start of our study, the range of number of nevi in the chemotherapy group was 0-133, in the control group 2-199.

Description:

Objectives:

Patients given chemotherapy because of different malignancies have an increased susceptibility to cutaneous tumours and infection and a change of number of nevi during treatment is discussed. We investigated wether total nevi count changes in children undergoing chemotherapy. Therefore 16 (8m, 8f) children suffering from leukaemia (11), lymphoma (2), adenosarcoma of the kidney (1), Ewing´s sarcoma (1) and neuroblastoma (1) aged between 2 and 17 years (median:8 years), under chemotherapy at the pediatric department of oncology, were examined at the beginning and 9-12 months after starting chemotherapy. As control group age and sex matched children of the local population were used.

Materials and Methods:

At the beginning of chemotherapy the nevi were counted on the total body. All nevi were larger in diameter than 1mm and as melanocytic lesion identifiable. Clinical and dermoscopic photographs were taken of every nevus. If the patient had more than 50 nevi, only nevi on the face, right arm, upper back and the buttocks were documented. Reassessment was repeated every 3 month.

Conclusion:

In our patients under chemotherapy during one year the development of new nevi is similar to sex and age matched children of the general population. During this short period development of nevi seems not to be influenced by chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patient and/or parents willing to participate in the study

• Age under 18

Study Group Only:

• Patient suffering from a malignancy requiring systemic chemotherapy

Exclusion Criteria:

• Patient and/or parents who decline to participate in the study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nevus
• Nevus, Pigmented

Locations

Country	Name	City	State
Austria	Department of Dermatology, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total body nevus count		Every three months during a one year period	No