Clinical trial NCT00600431: Melanocytic Nevi in Children Under Chemotherapy
Official title: Melanocytic-Nevi-Counts During Chemotherapy of Children With Malignancies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nevus, Pigmented
Keywords: nevus count
children
chemotherapy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 32
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study group: children suffering from malignancies requiring chemotherapy were recruited consecutively at the department of pediatric oncology

Control group: children were recruited consecutively at our department for pigmented skin lesions at the department of dermatology

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: total body nevus count
timeFrame: Every three months during a one year period
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Dermatology, Medical University of Graz
Study officials:
affiliation: Department of Dermatology, Medical University of Graz, Austria
name: Barbara Binder, MD
role: STUDY_CHAIR
References: