Melanoma Stage IIINCT05445752
Conservative Nodal Surgery (Node-picking) of Patients With Stage III Melanoma With Low-burden of Nodal Disease (MELCONSURG MULTICENTRE COHORT)
An observational study of Melanoma Stage III, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
Background: Standard treatment for stage III melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Melanoma Stage III
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Adult, Older adult
Study population: Melanoma patients (stage III N1b or N2b) fulfilling inclusion criteria and with no exclusion criteria managed at any of the participant centers.
Who may be able to join
- Patients with melanoma aged between 18 and 90 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Nodal stage N1b or N2b (American Joint Committee on Cancer 8th edition) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan).
Who cannot join
- Single lymph node metastasis in more than one regional basin.
- Multiple primary melanoma (except for limb melanoma).
- Primary occult melanoma.
- Previous nodal, locoregional, or distant metastasis.
- Previous lymph node surgery, except for SLNB.
- Distant metastases detected at the screening evaluations or first postoperative PET-CT scan.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Dermatology Department. University Hospital Virgen Macarena
Seville, 41008
David Moreno-Ramírez, PhD, Prof., 0034697959068, david.moreno.ramirez.sspa@juntadeandalucia.es
About this study
Background: Standard treatment for stage III melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. Conservative surgery for low-burden nodal metastasis involves removal of the metastatic lymph node or nodes ("node-picking"), leaving uninvolved nodes within the regional basin. This is expected to provide adequate regional control of the disease with no negative impact on patient survival and a lower rate of surgical complications.
Aims: The MelConSurg Cohort will provide the first data on conservative surgery for patients with stage III melanoma with nodal metastases detected clinically or by imaging.
Read more
Methods: A multicentre, single-arm prospective cohort study. Inclusion criteria: Patients with melanoma aged between 18 and 90 years, Eastern Cooperative Oncology Group performance status 0-1, non-matted regional lymph node metastasis (N1b or N2b) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan). Study period: A 3-year recruitment period and a 3-year follow-up phase.
Intervention: Patients will undergo conservative nodal surgery using conventional surgery, radio-guided surgery, or imaging guided surgery.
Outcome measures: 3-year nodal relapse-free survival, 3-year disease-free survival, 3-year melanoma-specific survival, rate of surgical complications, and quality of life (SF-36 questionnaire).
Sample size \& Statistics: the estimated sample size to be recruited is 68 patients. Survival outcomes will be analysed through the Kaplan-Meier method, with the log-rank test. Conclusions: This Project is expected to provide unique evidence regarding a less radical nodal surgery for patients with melanoma. If favourable results are obtained, controlled studies could be conducted and changes in current clinical practice could be considered.
- Conditions
- Melanoma Stage III
- Keywords
- Surgery, Lymph node dissection, Conservative nodal surgery, Lymph node metastasis, Melanoma, Stage III melanoma
- Medical subject headings
- Melanoma, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodal relapse-free survival
The primary outcome measure is the frequency and time to develop recurrence in the same nodal basin.
Measured: 3-year
Secondary outcomes (4)
Disease-free survival
Frequency and time to develop recurrence at any site, both regional or at distance.
Measured: 3-year
Melanoma-specific survival
Frequency and time to death directly related to melanoma progression.
Measured: 3-year
Surgical complication rate
Frequency of long-term complications (seroma, lymphedema, nerve injury, others). health-related quality of life questionnaire.
Measured: 3-year
Quality of life
Quality of life as tested by the SF-36 health-related quality of life questionnaire.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Stage IIIStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445752
- Sponsor's protocol ID
- MELCONSURG
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Nodal Surgery (Node-picking) of Patients With Stage III Melanoma With Low-burden of Nodal Disease (MELCONSURG MULTICENTRE COHORT)
- ClinicalTrials.gov ID
- NCT05445752
- Acronym / sponsor ID
- MELCONSURG
- Conditions
- Melanoma Stage III
- Keywords
- Surgery, Lymph node dissection, Conservative nodal surgery, Lymph node metastasis, Melanoma, Stage III melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- 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.
Background: Standard treatment for stage III melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. Conservative surgery for low-burden nodal metastasis involves removal of the metastatic lymph node or nodes ("node-picking"), leaving uninvolved nodes within the regional basin. This is expected to provide adequate regional control of the disease with no negative impact on patient survival and a lower rate of surgical complications.
Aims: The MelConSurg Cohort will provide the first data on conservative surgery for patients with stage III melanoma with nodal metastases detected clinically or by imaging.
Methods: A multicentre, single-arm prospective cohort study. Inclusion criteria: Patients with melanoma aged between 18 and 90 years, Eastern Cooperative Oncology Group performance status 0-1, non-matted regional lymph node metastasis (N1b or N2b) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan). Study period: A 3-year recruitment period and a 3-year follow-up phase.
Intervention: Patients will undergo conservative nodal surgery using conventional surgery, radio-guided surgery, or imaging guided surgery.
Outcome measures: 3-year nodal relapse-free survival, 3-year disease-free survival, 3-year melanoma-specific survival, rate of surgical complications, and quality of life (SF-36 questionnaire).
Sample size \& Statistics: the estimated sample size to be recruited is 68 patients. Survival outcomes will be analysed through the Kaplan-Meier method, with the log-rank test. Conclusions: This Project is expected to provide unique evidence regarding a less radical nodal surgery for patients with melanoma. If favourable results are obtained, controlled studies could be conducted and changes in current clinical practice could be considered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Melanoma patients (stage III N1b or N2b) fulfilling inclusion criteria and with no exclusion criteria managed at any of the participant centers.
Key inclusion criteria (3 listed)
- Patients with melanoma aged between 18 and 90 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Nodal stage N1b or N2b (American Joint Committee on Cancer 8th edition) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan).
Key exclusion criteria (6 listed)
- Single lymph node metastasis in more than one regional basin.
- Multiple primary melanoma (except for limb melanoma).
- Primary occult melanoma.
- Previous nodal, locoregional, or distant metastasis.
- Previous lymph node surgery, except for SLNB.
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
Nodal relapse-free survival
Time frame: 3-year
The primary outcome measure is the frequency and time to develop recurrence in the same nodal basin.
4 secondary outcomes
Disease-free survival
Time frame: 3-year
Melanoma-specific survival
Time frame: 3-year
Surgical complication rate
Time frame: 3-year
Quality of life
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Stage III, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Moreno-Ramírez, PhD, Prof. (0034697959068, david.moreno.ramirez.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodal relapse-free survival (time frame: 3-year). 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 6 Jul 2022.