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

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 Overview

• Status: Active, not recruiting
• Conditions: Adjuvant Treatment; Melanoma, Skin

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• France
  • Grand est
    • Vandoeuvre les Nancy, Grand est, France, 54500
      • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Actual): January 23, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Recurrence; Melanoma
• Other Study ID Numbers: 2024_PI_212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No