Minimal SN Tumor Burden (Minitub)
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|ClinicalTrials.gov Identifier: NCT01942603|
Recruitment Status : Recruiting
First Posted : September 16, 2013
Last Update Posted : July 17, 2018
The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not.
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||260 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
|Complete Lymfnode Dissection|
- Distant Metastasis Free Interval (DMFI) [ Time Frame: 5 years after last patient in ]
- Regional Control Rate (secondary endpoint): [ Time Frame: 5 years after last patient in ]
- Relapse Free Interval (RFI) [ Time Frame: 5 years after last patient in ]
- Melanoma Specific Survival (MSS) [ Time Frame: 5 years after last patient in ]
- Overall Survival (OS) [ Time Frame: 5 years after last patient in ]
- Morbidity: rates of wound infections, lymphedema and neurological damage [ Time Frame: 5 years after last patient in ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942603
|Contact: EORTC HQ||+32 2 774 email@example.com|
|Principal Investigator:||Alexander van Akkooi, MD, PhD||The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis|