Cutaneous MelanomaMinitubNCT01942603
Minimal SN Tumor Burden
An observational study of Cutaneous Melanoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 22 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- How many people
- 296 participants
- Where
- 22 sitesin 10 countries
- Study dates
- Jul 2009to Dec 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with minimal SN tumor burden
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
United Kingdom6 sites
Royal Bournemouth Hospital
Bournemouth
Cambridge University Hospital NHS - Addenbrookes Hospital
Cambridge
Guy's and St Thomas' NHS - St Thomas Hospital
London
St George's Hospital NHS Trust
London
Norfolk And Norwich Hospital
Norwich
St Helens & Knowsley NHS Trust - Whiston Hospital
Prescott
France3 sites
CHRU de Lille
Lille
CHU de Nice - Hopital De L'Archet
Nice
Institut Gustave Roussy
Paris
Germany3 sites
Charite - Universitaetsmedizin Berlin - Campus Mitte
Berlin
Universitaetsklinikum - Essen
Essen
UniversitaetsMedizin Mannheim
Mannheim
Italy3 sites
Istituto Europeo di Oncologia
Milan
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
Padova
Netherlands2 sites
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam
Erasmus MC Cancer Institute - location Daniel den Hoed
Rotterdam
About this study
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
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.
- Conditions
- Cutaneous Melanoma
- Keywords
- Minimal (SN) tumor burden, Stage III, Patients, Lymphnode Dissections
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described | |
| Complete Lymfnode Dissection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant Metastasis Free Interval (DMFI)
Measured: 5 years after last patient in
Secondary outcomes (5)
Regional Control Rate (secondary endpoint):
Measured: 5 years after last patient in
Relapse Free Interval (RFI)
Measured: 5 years after last patient in
Melanoma Specific Survival (MSS)
Measured: 5 years after last patient in
Overall Survival (OS)
Measured: 5 years after last patient in
Morbidity: rates of wound infections, lymphedema and neurological damage
Measured: 5 years after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJul 2009
- Primary completionDec 2023 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942603
- Sponsor's protocol ID
- EORTC-1208-MG
- Acronym
- Minitub
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2013
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01942603
- Acronym / sponsor ID
- Minitub / EORTC-1208-MG
- Conditions
- Cutaneous Melanoma
- Keywords
- Minimal (SN) tumor burden, Stage III, Patients, Lymphnode Dissections
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 296 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jul 2009
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | – | – |
| Complete Lymfnode Dissection | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with minimal SN tumor burden
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distant Metastasis Free Interval (DMFI)
Time frame: 5 years after last patient in
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 22 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, France, Germany, Italy, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant Metastasis Free Interval (DMFI) (time frame: 5 years after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.