Melanoma (Skin)RIC-MelNCT03315468
French Clinical Datbase of Melanoma Patients (RIC-Mel)
An observational study of Melanoma (Skin), run by Nantes University Hospital at 1 site in France.
Trial summary
With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- How many people
- 16,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2012to 1 Mar 2030
- 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 melanoma
Who may be able to join
- Patient with melanoma, of any stage,
- Patient agreed to participate.
Who cannot join
- Individuals under court protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gaëlle Quereux, PU-PH contact
Amir Khammari contact
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44093
Gaëlle Quereux, PU-PH, gaelle.quereux@chu-nantes.fr
About this study
Official title: French National Cohort of Patients With Melanoma (Any Stage). Network for Research and Clinical Investigation, the RIC-Mel Network.
With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients.
To meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :
Read more
RIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network are to promote translational and epidemiological projects as well as to optimize the achievements of clinical trials.
To achieve these goals, a database was launched in 2012 that gives a permanently updates mapping of melanoma treated in France with the key information needed for any research projects.
Read the detailed description
The RIC-Mel network federate clinicians researchers working in clinical and translational research for melanoma and carrying out patients inclusions in the clinical trials. These clinicians are working on clinical cancerology and dermatology sites located throughout the French national territory. Nowadays, the RIC-Mel network consists of 49 centers: 43 public dermatology centers (Hospital centers) and 6 private centers (Cancer centers). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris).
The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group of the French Society of Dermatology.
The RIC-Mel database has been approved by French health authorities, both ethically and for confidentiality of data (CCTIRS and CNIL). The database is available on the internet at any given moment thanks to a secure connection. All data are treated confidentially. The active file of patients with melanoma from each participating center is available in the database. All patients agreed to participate may be included in the database, regardless of their stage. Clinical data are collected thanks two forms :
- Part I key clinical data for any clinical trial Primary tumour (date of surgery, breslow…), lymph node removal (date, number of invaded lymph node…), AJCC stage, Mutation status, melanoma antigens, melanoma treatments (type, dates) and death.
- Part II: additional data for epidemiological and translational research Family history of melanoma, metastases (type, date of diagnosis…), HLA A and B type, additional information on treatments (dose, overall response, grade 3 or 4 side effects with the type, action on treatment and outcome).
In September 2017, more than 20,000 patients with melanoma had been included in the RIC-Mel database, with the following distribution: around 75% of primary stages (0 to II) and 25 % of metastatic stages (III and IV).
- Conditions
- Melanoma (Skin)
- Keywords
- melanoma, database, cohort
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of melanoma patients included in the RIC-Mel database
Overall survival if defined as the time between the primary melanoma tumour removal and the death or the date of data extraction from the RIC-Mel database for alive patients.
Measured: 5 years
Secondary outcomes (8)
Percentage of melanoma patients included in the RIC-Mel database categorized by genders
Distribution of females and males
Measured: through study completion, an average of 5 years
Percentage of melanoma patients included in the RIC-Mel database categorized by histological subtypes
Histological subtypes of primary melanoma were categorized as Superficial spreading melanoma, nodular, lentigo maligna melanoma, acral lentiginous melanoma, mucosal, ocular, unknown primary melanoma, and others subtypes. This information is collected from medical records of each patient
Measured: Day 1
Percentage of melanoma patients included in the RIC-Mel database categorized by breslow thickness
Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. Breslow thickness is the one of the important prognostic factor and it is commonly reported that the higher the Breslow thickness, the worse the prognosis. This information is collected from medical records of each patient. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown.
Measured: day 1
Percentage of melanoma patients included in the RIC-Mel database categorized by ulceration
Ulceration is defined as an erosion of the first primary tumour, associated with the death of cancer cells in the tumour center. Ulceration is, with breslow thickness, another important prognostic factor. Ulceration is associated with a worth prognostic. This information is collected from medical records of each patient. The classifications were Yes, No and Unknown.
Measured: day 1
Percentage of melanoma patients included in the RIC-Mel database categorized by Melanoma stage
Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as 0 (in situ melanoma), I and II (only primary tumour without any metastasis), III (locally advanced stage of melanoma regarding location of the primary tumour with lymph nodes and/or cutaneous metastasis), IV (advanced stage of melanoma with lymph nodes and/or cutaneous distant metastasis or any other type of metastasis). This information is collected from medical records of each patient
Measured: day 1
Percentage of Participants With Mutation Status
Presence or absence of mutations in the BRAF, NRAS and ckit oncogenes were determined thanks to each's centres practices. This information is collected from medical records of each patient.The classifications for each gene were Yes (mutated), No (non-mutated = wild type) and Unknown (no research).
Measured: Day 1
Percentage of treatment types among melanoma stage
Possible treatments types: Radiotherapy, Immunotherapy, Targeted therapies, Chemotherapy, Experimental treatment, Interferon, Others (for surgical approaches). All treatments reported in the RIC-Mel database only concerned those provided in the care of melanoma. This information is collected from medical records of each patient.
Measured: through study completion, an average of 5 years
Progression-free survival of melanoma patients included in the RIC-Mel database
Progression-free survival if defined as the time between the primary melanoma tumour removal and the appearance of the first metastasis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Mar 2012
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CENGEPS, Bristol-Myers Squibb, Hoffmann-La Roche, GlaxoSmithKline, Amgen
- Responsible party
- Sponsor
- Investigators
- Gaëlle Quereux, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315468
- Sponsor's protocol ID
- Prog 09/37-11
- Acronym
- RIC-Mel
- Status last verified
- Jul 2025
- First submitted
- 6 Oct 2017
- Last updated
- 22 Jul 2025
- 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French National Cohort of Patients With Melanoma (Any Stage). Network for Research and Clinical Investigation, the RIC-Mel Network.
- ClinicalTrials.gov ID
- NCT03315468
- Acronym / sponsor ID
- RIC-Mel / Prog 09/37-11
- Conditions
- Melanoma (Skin)
- Keywords
- melanoma, database, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- CENGEPS, Bristol-Myers Squibb, Hoffmann-La Roche, GlaxoSmithKline, Amgen
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 20 Oct 2017 (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.
With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients.
To meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :
RIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network are to promote translational and epidemiological projects as well as to optimize the achievements of clinical trials.
To achieve these goals, a database was launched in 2012 that gives a permanently updates mapping of melanoma treated in France with the key information needed for any research projects.
Detailed description
The RIC-Mel network federate clinicians researchers working in clinical and translational research for melanoma and carrying out patients inclusions in the clinical trials. These clinicians are working on clinical cancerology and dermatology sites located throughout the French national territory. Nowadays, the RIC-Mel network consists of 49 centers: 43 public dermatology centers (Hospital centers) and 6 private centers (Cancer centers). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris).
The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group of the French Society of Dermatology.
The RIC-Mel database has been approved by French health authorities, both ethically and for confidentiality of data (CCTIRS and CNIL). The database is available on the internet at any given moment thanks to a secure connection. All data are treated confidentially. The active file of patients with melanoma from each participating center is available in the database. All patients agreed to participate may be included in the database, regardless of their stage. Clinical data are collected thanks two forms :
- Part I key clinical data for any clinical trial Primary tumour (date of surgery, breslow…), lymph node removal (date, number of invaded lymph node…), AJCC stage, Mutation status, melanoma antigens, melanoma treatments (type, dates) and death.
- Part II: additional data for epidemiological and translational research Family history of melanoma, metastases (type, date of diagnosis…), HLA A and B type, additional information on treatments (dose, overall response, grade 3 or 4 side effects with the type, action on treatment and outcome).
In September 2017, more than 20,000 patients with melanoma had been included in the RIC-Mel database, with the following distribution: around 75% of primary stages (0 to II) and 25 % of metastatic stages (III and IV).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with melanoma
Key inclusion criteria (2 listed)
- Patient with melanoma, of any stage,
- Patient agreed to participate.
Key exclusion criteria (1 listed)
- Individuals under court protection
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
Overall survival of melanoma patients included in the RIC-Mel database
Time frame: 5 years
Overall survival if defined as the time between the primary melanoma tumour removal and the death or the date of data extraction from the RIC-Mel database for alive patients.
8 secondary outcomes
Percentage of melanoma patients included in the RIC-Mel database categorized by genders
Time frame: through study completion, an average of 5 years
Percentage of melanoma patients included in the RIC-Mel database categorized by histological subtypes
Time frame: Day 1
Percentage of melanoma patients included in the RIC-Mel database categorized by breslow thickness
Time frame: day 1
Percentage of melanoma patients included in the RIC-Mel database categorized by ulceration
Time frame: day 1
Percentage of melanoma patients included in the RIC-Mel database categorized by Melanoma stage
Time frame: day 1
Percentage of Participants With Mutation Status
Time frame: Day 1
Percentage of treatment types among melanoma stage
Time frame: through study completion, an average of 5 years
Progression-free survival of melanoma patients included in the RIC-Mel database
Time frame: 5 years
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 22 Jul 2025.
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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.
Gaëlle Quereux, PU-PH contact
Amir Khammari contact
Gaëlle Quereux, PU-PH principal investigator
Nantes University Hospital
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 (Skin), run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. 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 France. 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?
Contact Gaëlle Quereux, PU-PH (gaelle.quereux@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of melanoma patients included in the RIC-Mel database (time frame: 5 years). 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 22 Jul 2025.