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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
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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
Cutaneous Melanoma

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 260 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort
Observation
Complete Lymfnode Dissection



Primary Outcome Measures :
  1. Distant Metastasis Free Interval (DMFI) [ Time Frame: 5 years after last patient in ]

Secondary Outcome Measures :
  1. Regional Control Rate (secondary endpoint): [ Time Frame: 5 years after last patient in ]
  2. Relapse Free Interval (RFI) [ Time Frame: 5 years after last patient in ]
  3. Melanoma Specific Survival (MSS) [ Time Frame: 5 years after last patient in ]
  4. Overall Survival (OS) [ Time Frame: 5 years after last patient in ]
  5. Morbidity: rates of wound infections, lymphedema and neurological damage [ Time Frame: 5 years after last patient in ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with minimal SN tumor burden
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • 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:

  • 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 -

Information from the National Library of Medicine

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


Contacts
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Contact: EORTC HQ +32 2 774 1611 1208@eortc.org

Locations
Show Show 22 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Principal Investigator: Alexander van Akkooi, MD, PhD The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Additional Information:

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01942603    
Other Study ID Numbers: EORTC-1208-MG
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Minimal (SN) tumor burden
Stage III
Patients
Lymphnode Dissections
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas