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CompletedNCT00600431Updated Jan 25, 2008

Melanocytic Nevi in Children Under Chemotherapy

An observational study in Nevus, Pigmented, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-25.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
32
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nevus, Pigmented

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Keywords

  • nevus count
  • children
  • chemotherapy
03

In context

Nevus, Pigmented

19 studies on the registry are indexed under Nevus, Pigmented; 6 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 11 observational studies indexed under Nevus, Pigmented.

Browse Nevus, Pigmented studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient and/or parents willing to participate in the study
  • Age under 18

Study Group Only:

  • Patient suffering from a requiring systemic chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Patient and/or parents who decline to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
32 participants (actual)

Groups and 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

06

What researchers measure

Primary outcomes

  1. total body nevus count

    Time frame: Every three months during a one year period

07

Study locations

1 site
  • Department of Dermatology, Medical University of Graz
    Graz, 8036, Austria
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2006, a primary completion of Dec 2007 and a completion of Dec 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2008
First posted
Jan 25, 2008
Start
Feb 2006
Primary completionActual
Dec 2007
CompletionActual
Dec 2007
Last update
Jan 25, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00600431
First posted
Jan 25, 2008
Start date
Feb 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jan 25, 2008

Study contacts

Barbara Binder, MD
study chair · Department of Dermatology, Medical University of Graz, Austria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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