Melanoma, SkinMELASENTINCT06809491
One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy
An observational study of Melanoma, Skin and Adjuvant Treatment, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Melanoma is one of the most aggressive solid cancers, although mortality can be reduced with early treatment. Immunotherapy has transformed the prognosis of this pathology. The sentinel lymph node technique is used to classify the severity of melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin, Adjuvant Treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2025to 31 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed at the CHRU de Nancy or at the ICL between 01/01/2019 and 31/12/2023 and who does not object to the collection of his/her data.
Who may be able to join
- Major patient with a melanoma with a Breslow index greater than 0.8mm or ulcerated melanoma, non-metastatic at diagnosis,
Who cannot join
- Metastatic patient
- Minor patient
- Melanoma with a Breslow index of less than 0.8mm and not ulcerated
- Patient objecting to data collection
Trial locations and contacts
1 site in 1 country.
About this study
Melanoma is one of the most aggressive solid cancers, although mortality can be reduced with early treatment. Immunotherapy has transformed the prognosis of this pathology.
The sentinel lymph node technique is used to classify the severity of melanoma. It is proposed for melanomas with a Breslow thickness of 0.8 mm to 1 mm, and recommended for melanomas greater than 1 mm or with ulceration, whatever the Breslow index.
Read more
This technique is particularly useful for assessing pathology by detecting the presence of lymph node metastases. Patients with lymph node involvement (micro or macro) are eligible for adjuvant treatment.
The new recommendations suggest adjuvant immunotherapy for stages IIB and IIC (without lymph node involvement assessed by the sentinel lymph node technique). This procedure is widely used at the CHRU de NANCY.
The aim of this study is to demonstrate the value of the sentinel lymph node in assessing the risk of melanoma recurrence at one year (or more).
- Conditions
- Melanoma, Skin, Adjuvant Treatment
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or recurrence one year after diagnosis
Death or recurrence one year after diagnosis measured through the one-year reassessment (clinical or radiological evaluation).
Measured: 1 year
Secondary outcomes (7)
Overall survival
To evaluate the overall survival one year after diagnosis in melanoma patients eligible for a sentinel lymph node biopsy.
Measured: 4 years
predictive factors of mortality or recurrence one year after diagnosis
To evaluate the predictive factors of mortality or recurrence one year after diagnosis in melanoma patients eligible for a sentinel lymph node biopsy.
Measured: 4 years
the recurrence-free survival
To evaluate the recurrence-free survival of melanoma patients eligible for a sentinel lymph node biopsy.
Measured: 4 years
complications associated with the sentinel lymph node biopsy
To evaluate the complications associated with the sentinel lymph node biopsy.
Measured: 4 years
recurrence-free survival of patients over 70 years old
To evaluate the recurrence-free survival of patients over 70 years old with melanoma eligible for a sentinel lymph node biopsy.
Measured: 4 years
post-sentinel lymph node biopsy treatments
To describe post-sentinel lymph node biopsy treatments
Measured: 4 years
the tolerance of adjuvant treatment.
To document the tolerance of adjuvant treatment.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start23 Jan 2025
- Primary completion23 Jan 2025
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma, SkinStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Claire BURSZTEJN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809491
- Sponsor's protocol ID
- 2024_PI_212
- Acronym
- MELASENTI
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy
- ClinicalTrials.gov ID
- NCT06809491
- Acronym / sponsor ID
- MELASENTI / 2024_PI_212
- Conditions
- Melanoma, Skin, Adjuvant Treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 5 Feb 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.
Melanoma is one of the most aggressive solid cancers, although mortality can be reduced with early treatment. Immunotherapy has transformed the prognosis of this pathology.
The sentinel lymph node technique is used to classify the severity of melanoma. It is proposed for melanomas with a Breslow thickness of 0.8 mm to 1 mm, and recommended for melanomas greater than 1 mm or with ulceration, whatever the Breslow index.
This technique is particularly useful for assessing pathology by detecting the presence of lymph node metastases. Patients with lymph node involvement (micro or macro) are eligible for adjuvant treatment.
The new recommendations suggest adjuvant immunotherapy for stages IIB and IIC (without lymph node involvement assessed by the sentinel lymph node technique). This procedure is widely used at the CHRU de NANCY.
The aim of this study is to demonstrate the value of the sentinel lymph node in assessing the risk of melanoma recurrence at one year (or more).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at the CHRU de Nancy or at the ICL between 01/01/2019 and 31/12/2023 and who does not object to the collection of his/her data.
Key inclusion criteria (1 listed)
- Major patient with a melanoma with a Breslow index greater than 0.8mm or ulcerated melanoma, non-metastatic at diagnosis,
Key exclusion criteria (4 listed)
- Metastatic patient
- Minor patient
- Melanoma with a Breslow index of less than 0.8mm and not ulcerated
- Patient objecting to data collection
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
Death or recurrence one year after diagnosis
Time frame: 1 year
Death or recurrence one year after diagnosis measured through the one-year reassessment (clinical or radiological evaluation).
7 secondary outcomes
Overall survival
Time frame: 4 years
predictive factors of mortality or recurrence one year after diagnosis
Time frame: 4 years
the recurrence-free survival
Time frame: 4 years
complications associated with the sentinel lymph node biopsy
Time frame: 4 years
recurrence-free survival of patients over 70 years old
Time frame: 4 years
post-sentinel lymph node biopsy treatments
Time frame: 4 years
the tolerance of adjuvant treatment.
Time frame: 4 years
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 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Skin and Adjuvant Treatment, run by Central Hospital, Nancy, France 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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 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?
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?
Death or recurrence one year after diagnosis (time frame: 1 year). 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 Feb 2025.