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

N/AActive Not RecruitingNCT06809491

Central Hospital, Nancy, France200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Melanoma, Skin Adjuvant Treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Death or recurrence one year after diagnosis

Death or recurrence one year after diagnosis measured through the one-year reassessment (clinical or radiological evaluation).

Time frame: 1 year

Secondary Outcomes

Overall survival

To evaluate the overall survival one year after diagnosis in melanoma patients eligible for a sentinel lymph node biopsy.

Time frame: 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.

Time frame: 4 years

the recurrence-free survival

To evaluate the recurrence-free survival of melanoma patients eligible for a sentinel lymph node biopsy.

Time frame: 4 years

complications associated with the sentinel lymph node biopsy

To evaluate the complications associated with the sentinel lymph node biopsy.

Time frame: 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.

Time frame: 4 years

post-sentinel lymph node biopsy treatments

To describe post-sentinel lymph node biopsy treatments

Time frame: 4 years

the tolerance of adjuvant treatment.

To document the tolerance of adjuvant treatment.

Time frame: 4 years