Clinical trial NCT03210935: French National Database of Rare Dermatological Cancers
Official title: French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adnexal Tumor of Skin
Merkel Cell Carcinoma
Advanced Basal Cell Carcinoma Requiring Systemic Treatment
Keywords: Adnexal cutaneous carcinoma
Merkel cell carcinoma
Advanced basal cell carcinoma requiring systemic treatment
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 9000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma

Brief summary: Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown in terms of natural behavior, prognosis, treatment and outcomes.

CARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are :

* to provide epidemiological, clinical and socio-economic characteristics of patients
* to identify new clinical or epidemiological prognostic factors for these rare cancers
* to evaluate the impact of various treatments on outcomes

Detailed description: CARADERM is a French national multidisciplinary project which will prospectively enroll from 37 French centers any patient presenting with Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment or cutaneous adnexal carcinoma.

A structured and centralized database of clinical monitoring of patients will be established. Information captured will include clinical constitutional factors, factors linked to primary carcinoma, factors linked to lymph node involvement, "American Joint Committee on Cancer" (AJCC) stage at inclusion, recurrence patterns, therapeutic interventions (medical, surgical, radiotherapy and palliative strategies) with evaluation of response, date of death, date of latest news.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma

Exclusion Criteria:

* Subjects without Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma
* Patients refusal

Primary outcomes:
measure: Incidence and natural history of the 3 types of rare skin cancers
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: CH Annecy Gennevois
city: Besançon
country: France
facility: CHU Besançon
city: Bobigny
country: France
facility: CHU Avicenne
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Dijon
country: France
facility: CHU Bocage
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Mans
country: France
facility: CH Le Mans
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hôpital La Timone
city: Montpellier
country: France
facility: Hôpital St Eloi
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU Nantes - Place Alexis Ricordeau
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: CHR d'Orleans
city: Paris
country: France
facility: CHU Bichat
city: Paris
country: France
facility: CHU Cochin
city: Paris
country: France
facility: CHU St Louis
city: Pessac
country: France
facility: CHU de Bordeaux
city: Pierre-benite
country: France
facility: Centre hospitalier Lyon Sud
city: Pointe À Pitre
country: France
facility: CHU de Pointe à Pitre
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse - Larrey
city: Tours
country: France
facility: CHU de Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: University Hospital, Lille
name: Laurent MORTIER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: