Nevus, PigmentedNCT00600431
Melanocytic Nevi in Children Under Chemotherapy
An observational study of Nevus, Pigmented, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Nevus, Pigmented
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Patient and/or parents willing to participate in the study
- Age under 18
- Study Group Only:
- Patient suffering from a malignancy requiring systemic chemotherapy
Who cannot join
- Patient and/or parents who decline to participate in the study
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Dermatology, Medical University of Graz
Graz, 8036
About this study
Official title: 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.
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.
- Conditions
- Nevus, Pigmented
- Keywords
- nevus count, children, chemotherapy
- Medical subject headings
- Nevus, Pigmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
total body nevus count
Measured: Every three months during a one year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startFeb 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nevus, PigmentedStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Binder, MD, Study chair, Department of Dermatology, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600431
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2008
- First submitted
- 14 Jan 2008
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanocytic-Nevi-Counts During Chemotherapy of Children With Malignancies.
- ClinicalTrials.gov ID
- NCT00600431
- Acronym / sponsor ID
- 001
- Conditions
- Nevus, Pigmented
- Keywords
- nevus count, children, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Study group: 16 children under 18 years undergoing systemic chemotherapy |
| 2 | – | –Control group: 16 age and sex matched healthy children under 18 years |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- Patient and/or parents willing to participate in the study
- Age under 18
- Patient suffering from a malignancy requiring systemic chemotherapy
Key exclusion criteria (1 listed)
- Patient and/or parents who decline to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
total body nevus count
Time frame: Every three months during a one year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Binder, MD study chair
Department of Dermatology, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nevus, Pigmented, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total body nevus count (time frame: Every three months during a one year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2008; AzTrials last refreshed its copy on 7 Nov 2026.