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Trial record 45 of 2318 for:    melanoma

French Clinical Datbase of Melanoma Patients (RIC-Mel) (RIC-Mel)

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ClinicalTrials.gov Identifier: NCT03315468
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

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.


Condition or disease
Melanoma (Skin)

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

Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: French National Cohort of Patients With Melanoma (Any Stage). Network for Research and Clinical Investigation, the RIC-Mel Network.
Actual Study Start Date : March 1, 2012
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time delay in years until diagnosis of the first primary melanoma tumour of melanoma patients included in the RIC-Mel database [ Time Frame: From birth to the time of the first primary melanoma removal ]
  2. Percentage of melanoma patients included in the RIC-Mel database categorized by genders [ Time Frame: through study completion, an average of 5 years ]
    Distribution of females and males

  3. Percentage of melanoma patients included in the RIC-Mel database categorized by histological subtypes [ Time Frame: Day 1 ]
    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

  4. Percentage of melanoma patients included in the RIC-Mel database categorized by breslow thickness [ Time Frame: day 1 ]
    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.

  5. Percentage of melanoma patients included in the RIC-Mel database categorized by ulceration [ Time Frame: day 1 ]
    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.

  6. Percentage of melanoma patients included in the RIC-Mel database categorized by Melanoma stage [ Time Frame: day 1 ]
    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

  7. Percentage of Participants With Mutation Status [ Time Frame: Day 1 ]
    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).

  8. Percentage of treatment types among melanoma stage [ Time Frame: through study completion, an average of 5 years ]
    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.

  9. Progression-free survival of melanoma patients included in the RIC-Mel database [ Time Frame: 5 years ]
    Progression-free survival if defined as the time between the primary melanoma tumour removal and the appearance of the first metastasis.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with melanoma
Criteria

Inclusion Criteria:

  • Patient with melanoma, of any stage,
  • Patient agreed to participate.

Exclusion Criteria:

  • Patient with melanoma disagreed to participate
Contacts and Locations

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): NCT03315468


Contacts
Contact: Brigitte DRENO, PU-PH +33.02.40.08.31.37
Contact: Emilie Varey +33 02.40.08.78.85 emilie.varey@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Brigitte DRENO, PU-PH    +33 02.40.08.31.37      
Contact: Emilie VAREY    +33 02.40.08.78.85    emilie.varey@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
CENGEPS
Bristol-Myers Squibb
Hoffmann-La Roche
GlaxoSmithKline
Amgen
Investigators
Principal Investigator: Brigitte DRENO, PU-PH CHU Nantes
More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03315468     History of Changes
Other Study ID Numbers: Prog 09/37-11
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
melanoma
database
cohort

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas