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

NCT ID: NCT06809491

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-23

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma, Skin Adjuvant Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anne Claire BURSZTEJN

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU Nancy

Vandœuvre-lès-Nancy, Grand Est, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024_PI_212

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.