NCT00600431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

January 14, 2008

Last Update Submit

January 24, 2008

Conditions

Nevus, Pigmented

Keywords

nevus countchildrenchemotherapy

Outcome Measures

Primary Outcomes (1)

  • total body nevus count

    Every three months during a one year period

Study Arms (2)

1

Study group: 16 children under 18 years undergoing systemic chemotherapy

2

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Patient and/or parents willing to participate in the study
  • Age under 18
  • Study Group Only:
  • Patient suffering from a malignancy requiring systemic chemotherapy

You may not qualify if:

  • Patient and/or parents who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Nevus, Pigmented

Condition Hierarchy (Ancestors)

NevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Barbara Binder, MD

    Department of Dermatology, Medical University of Graz, Austria

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

February 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

AU(1)