Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
296 participants
OBSERVATIONAL
2009-07-31
2031-12-31
Brief Summary
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Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry.
The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Observation
No interventions assigned to this group
Complete Lymfnode Dissection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histological evidence of primary cutaneous melanoma
* Metastases solely confined within the SN:
* in the sub-capsular space (with no parenchymal infiltration) and with a maximum diameter of the largest metastasis not greater than 0.4 mm or
* regardless of the site, any sub-micrometastasis with a maximum diameter not greater than 0.1 mm If there is more than 1 metastatic SN, the patient will be still eligible provided that all involved SN have minimal tumor burden, regardless of the amount of positive SNs and the interested basin
Exclusion Criteria
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial -
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Locations
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U.Z. Leuven - Campus Gasthuisberg
Leuven, , Belgium
CHRU de Lille
Lille, , France
CHU de Nice - Hopital De L'Archet
Nice, , France
Institut Gustave Roussy
Paris, , France
Charite - Universitaetsmedizin Berlin - Campus Mitte
Berlin, , Germany
Universitaetsklinikum - Essen
Essen, , Germany
UniversitaetsMedizin Mannheim
Mannheim, , Germany
Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Napoli, , Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
Padua, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed
Rotterdam, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, , Poland
The Institute Of Oncology
Ljubljana, , Slovenia
Hospital Clinic Universitari
Barcelona, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital
Cambridge, , United Kingdom
Guy's and St Thomas' NHS - St Thomas Hospital
London, , United Kingdom
St George's Hospital NHS Trust
London, , United Kingdom
Norfolk And Norwich Hospital
Norwich, , United Kingdom
St Helens & Knowsley NHS Trust - Whiston Hospital
Prescott, , United Kingdom
Countries
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Other Identifiers
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EORTC-1208-MG
Identifier Type: -
Identifier Source: org_study_id