Congenital Melanocytar Nevi in the Lower LimbNAEVUSNCT04297579
Congenital Naevi of Lower Limb in the Child
An observational study of Congenital Melanocytar Nevi in the Lower Limb, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Melanocytar Nevi in the Lower Limb
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 1984to 1 May 2020
- 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
- No healthy volunteers
- Child, Adult
Study population: Children that had congenital nevi surgery removal, in the lower limb.
Who may be able to join
- Child + congenital nevi in the lower limb + had removal surgery
Who cannot join
- More than one congenital nevi in the lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?
Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.
This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.
Read the detailed description
Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.
- Keywords
- congenital nevi, naevus, Congenital skin neoplasm, Reconstructive surgical procedures
- Medical subject headings
- Nevus
What is being measured
The primary outcome is the main question the study is designed to answer.
Nevi Estimated Size
Nevi Estimated Size (centimeters)
Measured: within three weeks after surgery
Secondary outcomes (1)
post-operative complications depending on the initial size of the naevus
post-operative complications depending on the initial size of the naevus : percentage of complication rate
Measured: assessed within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 1984
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Melanocytar Nevi in the Lower LimbStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume CAPTIER, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297579
- Sponsor's protocol ID
- RECHMPL20_0063
- Acronym
- NAEVUS
- Status last verified
- Jun 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?
- ClinicalTrials.gov ID
- NCT04297579
- Acronym / sponsor ID
- NAEVUS / RECHMPL20_0063
- Keywords
- congenital nevi, naevus, Congenital skin neoplasm, Reconstructive surgical procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 1984 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 5 Mar 2020 (actual)
- 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.
Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.
This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.
Detailed description
Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children that had congenital nevi surgery removal, in the lower limb.
Key inclusion criteria (1 listed)
- Child + congenital nevi in the lower limb + had removal surgery
Key exclusion criteria (1 listed)
- More than one congenital nevi in the lower limb.
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
Nevi Estimated Size
Time frame: within three weeks after surgery
Nevi Estimated Size (centimeters)
1 secondary outcome
post-operative complications depending on the initial size of the naevus
Time frame: assessed within 6 months after surgery
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 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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.
Guillaume CAPTIER, MD.PhD study director
University Hospital, Montpellier
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 Congenital Melanocytar Nevi in the Lower Limb, run by University Hospital, Montpellier at 1 site in France.
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 1 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 5 Jun 2020. 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 France. 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?
Nevi Estimated Size (time frame: within three weeks after surgery). 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 5 Jun 2020.