Melanocytic Nevi in Children Under Chemotherapy

January 24, 2008 updated by: Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Department of Dermatology, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Study group: 16 children under 18 years undergoing systemic chemotherapy
2
Control group: 16 age and sex matched healthy children under 18 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total body nevus count
Time Frame: Every three months during a one year period
Every three months during a one year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Study Chair: Barbara Binder, MD, Department of Dermatology, Medical University of Graz, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (ESTIMATE)

January 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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