MelanomaNCT06861023
Review of the Literature and Serie of Patients Who Underwent Reconstruction After Wide Local Excision of Nail Apparatus for Melanoma
An observational study of Melanoma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Melanomas of the nail bed are often diagnosed at the locally advanced stage. The standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma
- What is being tested?
- Patients who have undergone extensive nail resection with reconstruction
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2025to 25 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who have undergone melanoma surgery in the plastic surgery department of the Pasteur Hospital
Who may be able to join
- Patients who have undergone enlarged resection of the nail apparatus with immediate or delayed reconstruction in the setting of acral melanoma of the fingers or toes.
Who cannot join
- Patients who have amputation, opposition of the pateint to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU NICE
Nice, Alpes Maritimes, 06000
ELISE LUPON
LUC CHOUQUET, 06 42 75 07 14 ext. +33, ettooluc@gmail.com
About this study
Official title: Review of the Literature and Retrospective, Single-centre Study of a Series of Patients Who Underwent Reconstruction After Complete Nail Resection.
Melanomas of the nail bed are often diagnosed at the locally advanced stage. The standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. Reconstruction of the nail system can be performed by several techniques. Here, the investigators present a series of patients reconstructed by INTEGRA (dermal matrix) and skin graft
- Conditions
- Melanoma
- Being tested
- Patients who have undergone extensive nail resection with reconstruction
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who have undergone extensive nail resection with reconstructionOther
Also called Excision of the nail apparatus with flap reconstruction or INTEGRA + skin graft.
The investigators studied a population of 10 patients who underwent nail and nail matrix excision surgery as part of the treatment of subungual melanoma, as well as the reconstruction, the investigators opted for. The specific intervention of this study is based on late postoperative questions (after 3 months)
| Study group | Role | What they receive |
|---|---|---|
| Patients who have undergone extensive nail resection with reconstruction | Not described Receives: Other: Patients who have undergone extensive nail resection with reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and cosmetic patient satisfaction
Scores AOFAS (feet)(score ranging from 0, maximum disability, to 90, no disability), Scores QUICK DASH(score ranging from 0, no disability, to 100, maximum disability) and Mayowrist score (hands)(score ranging from 0, maximum disability, to 100, no disability)
Measured: 3 months minimum postoperative
Secondary outcomes (2)
Post-operative complications
Presence or absence of Postoperative complications (inclusion cyst, nail spicule, need for repeat surgery).
Measured: 3 months minimum postoperative
Recurrence of the disease
Recurrence of the disease.
Measured: 3 months minimum postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Jan 2025
- Primary completion28 Feb 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861023
- Sponsor's protocol ID
- 25Chirplast01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of the Literature and Retrospective, Single-centre Study of a Series of Patients Who Underwent Reconstruction After Complete Nail Resection.
- ClinicalTrials.gov ID
- NCT06861023
- Acronym / sponsor ID
- 25Chirplast01
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 6 Mar 2025 (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.
Melanomas of the nail bed are often diagnosed at the locally advanced stage. The standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. Reconstruction of the nail system can be performed by several techniques. Here, the investigators present a series of patients reconstructed by INTEGRA (dermal matrix) and skin graft
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have undergone extensive nail resection with reconstruction | – | Other: Patients who have undergone extensive nail resection with reconstruction |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone melanoma surgery in the plastic surgery department of the Pasteur Hospital
Key inclusion criteria (1 listed)
- Patients who have undergone enlarged resection of the nail apparatus with immediate or delayed reconstruction in the setting of acral melanoma of the fingers or toes.
Key exclusion criteria (1 listed)
- Patients who have amputation, opposition of the pateint to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients who have undergone extensive nail resection with reconstructionAlso: Excision of the nail apparatus with flap reconstruction or INTEGRA + skin graft.The investigators studied a population of 10 patients who underwent nail and nail matrix excision surgery as part of the treatment of subungual melanoma, as well as the reconstruction, the investigators opted for. The specific intervention of this study is based on late postoperative questions (after 3 months) | Other | Patients who have undergone extensive nail resection with reconstruction |
Primary outcome
Functional and cosmetic patient satisfaction
Time frame: 3 months minimum postoperative
Scores AOFAS (feet)(score ranging from 0, maximum disability, to 90, no disability), Scores QUICK DASH(score ranging from 0, no disability, to 100, maximum disability) and Mayowrist score (hands)(score ranging from 0, maximum disability, to 100, no disability)
2 secondary outcomes
Post-operative complications
Time frame: 3 months minimum postoperative
Recurrence of the disease
Time frame: 3 months minimum postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
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 Melanoma, run by Centre Hospitalier Universitaire de Nice 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELISE LUPON (06 26 30 63 23 ext. + 33, lupon.e@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and cosmetic patient satisfaction (time frame: 3 months minimum postoperative). 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 6 Mar 2025.