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NCT Number: NCT06809491

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Overall survival

    Time frame: 4 years

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

  2. predictive factors of mortality or recurrence one year after diagnosis

    Time frame: 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.

  3. the recurrence-free survival

    Time frame: 4 years

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

  4. complications associated with the sentinel lymph node biopsy

    Time frame: 4 years

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

  5. recurrence-free survival of patients over 70 years old

    Time frame: 4 years

    To evaluate the recurrence-free survival of patients over 70 years old with melanoma eligible for a sentinel lymph node biopsy.

  6. post-sentinel lymph node biopsy treatments

    Time frame: 4 years

    To describe post-sentinel lymph node biopsy treatments

  7. the tolerance of adjuvant treatment.

    Time frame: 4 years

    To document the tolerance of adjuvant treatment.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: MELASENTI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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