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

NCT06809491 | Active Not Recruiting

• 1 other identifier: 2024_PI_212
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Melanoma, Skin; Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall survival

  4 years

• predictive factors of mortality or recurrence one year after diagnosis

  4 years

• the recurrence-free survival

  4 years

• complications associated with the sentinel lymph node biopsy

  4 years

• recurrence-free survival of patients over 70 years old

  4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, Grand Est, 54500, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 5, 2025
• Study Start: January 23, 2025
• Primary Completion: January 23, 2025
• Study Completion: January 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

FR (1)