One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06809491

Acronym

MELASENTI

Enrollment

200

Registered

2025-02-05

Start date

2025-01-23

Completion date

2025-01-31

Last updated

2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant Treatment, Melanoma, Skin

Brief 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. 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Major patient with a melanoma with a Breslow index greater than 0.8mm or ulcerated melanoma, non-metastatic at diagnosis,

Exclusion criteria

* Metastatic patient * Minor patient * Melanoma with a Breslow index of less than 0.8mm and not ulcerated * Patient objecting to data collection

Design outcomes

Primary

Measure	Time frame	Description
Death or recurrence one year after diagnosis	1 year	Death or recurrence one year after diagnosis measured through the one-year reassessment (clinical or radiological evaluation).

Secondary

Measure	Time frame	Description
the recurrence-free survival	4 years	To evaluate the recurrence-free survival of melanoma patients eligible for a sentinel lymph node biopsy.
complications associated with the sentinel lymph node biopsy	4 years	To evaluate the complications associated with the sentinel lymph node biopsy.
recurrence-free survival of patients over 70 years old	4 years	To evaluate the recurrence-free survival of patients over 70 years old with melanoma eligible for a sentinel lymph node biopsy.
the tolerance of adjuvant treatment.	4 years	To document the tolerance of adjuvant treatment.
Overall survival	4 years	To evaluate the overall survival one year after diagnosis in melanoma patients eligible for a sentinel lymph node biopsy.
predictive factors of mortality or recurrence one year after diagnosis	4 years	To evaluate the predictive factors of mortality or recurrence one year after diagnosis in melanoma patients eligible for a sentinel lymph node biopsy.
post-sentinel lymph node biopsy treatments	4 years	To describe post-sentinel lymph node biopsy treatments

Countries

France

Outcome results