Minitub: Prospective registry of Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissection (CLND) or Nodal Observatio

Recruiting

Conditions: Melanoma
Skin Cancer
10040900
10043413
10027476

Registration Number: NL-OMON43605

Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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 basin of interest
* Absence of clinically apparent metastatic disease at the time of or before undergoing a SN procedure
* Age >=18 years
* 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
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria

* No previous SN procedure for locally recurrent melanoma or uncertain malignant disease, such as atypical Spitz tumor/naevi
* No history of a previous melanoma (preceding the melanoma which prompted the SN biopsy)
* No history of any other malignancy within the past 5 years, except for non-melanoma skin cancer (Basal Cell Carcinomas or Squamous Cell Carcinomas) and in situ cervical cancer
* 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Distant Metastasis Free Interval (DMFI), defined as the time from SN positive<br /><br>biopsy until distant metastasis or death due to melanoma, whichever comes<br /><br>first. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Regional Control Rate (secondary endpoint):<br /><br>* Regional Metastasis Free Interval (RMFI): time from SN positive biopsy (date<br /><br>of surgical procedure) until regional relapse, on the same basin as the SN was<br /><br>previously removed.<br /><br>* Regional Control Rate (RCR): rate of lymph node relapse (date of delayed<br /><br>CLND) in the same basin as the SN was previously removed.<br /><br>Regional relapse does not include any local or in-transit recurrences.<br /><br>* Relapse Free Interval (RFI), defined as the time from SN positive biopsy<br /><br>until first relapse - regional or distant metastasis - or death due to melanoma.<br /><br>* Melanoma Specific Survival (MSS), defined as the time from SN positive biopsy<br /><br>until death due to melanoma.<br /><br>* Overall Survival (OS), defined as the time from SN positive biopsy until<br /><br>death due to any cause. </p><br>