Melanocytic Nevi in Children Under Chemotherapy

NCT ID: NCT00600431

Last Updated: 2008-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-12-31

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.

Conditions

Nevus, Pigmented

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Study group: 16 children under 18 years undergoing systemic chemotherapy

No interventions assigned to this group

2

Control group: 16 age and sex matched healthy children under 18 years

No interventions assigned to this group

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Department of Dermatology and Department of Pediatric Oncology, MU Graz

Principal Investigators

Barbara Binder, MD

Role: STUDY_CHAIR

Department of Dermatology, Medical University of Graz, Austria

Locations

Department of Dermatology, Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id