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Melanocytic Nevi in Children Under Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00600431
First received: January 14, 2008
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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.


Condition
Nevus, Pigmented

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Melanocytic-Nevi-Counts During Chemotherapy of Children With Malignancies.

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • total body nevus count [ Time Frame: Every three months during a one year period ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Study group: 16 children under 18 years undergoing systemic chemotherapy
2
Control group: 16 age and sex matched healthy children under 18 years

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600431

Locations
Austria
Department of Dermatology, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Study Chair: Barbara Binder, MD Department of Dermatology, Medical University of Graz, Austria
  More Information

No publications provided

Responsible Party: Binder Barbara, MD, Department of Dermatology and Department of Pediatric Oncology, MU Graz
ClinicalTrials.gov Identifier: NCT00600431     History of Changes
Other Study ID Numbers: 001
Study First Received: January 14, 2008
Last Updated: January 24, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
nevus count
children
chemotherapy

Additional relevant MeSH terms:
Nevus
Nevus, Pigmented
Neoplasms
Neoplasms by Histologic Type
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014