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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03210935
Other study ID # NI_2014_60
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 24, 2015
Est. completion date December 31, 2025

Study information

Verified date March 2021
Source University Hospital, Lille
Contact Laurent MORTIER, MD,PhD
Phone 03.20.44.41.93
Email laurent.mortier@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 9000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Picardie Amiens
France CHU Angers Angers
France CH Annecy Gennevois Annecy
France CHU Besançon Besançon
France CHU Avicenne Bobigny
France CHU Ambroise Paré Boulogne-Billancourt
France CHU de Brest Brest
France CHU de Caen Caen
France CHU de Clermont Ferrand Clermont Ferrand
France CHU Bocage Dijon
France CHU de Grenoble Grenoble
France CH Le Mans Le Mans
France CHU de Limoges Limoges
France Centre Léon Bérard Lyon
France Hôpital La Timone Marseille
France Hôpital St Eloi Montpellier
France CHU de Nancy Nancy
France CHU Nantes - Place Alexis Ricordeau Nantes
France CHU de Nice Nice
France CHR d'Orleans Orléans
France CHU Bichat Paris
France CHU Cochin Paris
France CHU St Louis Paris
France CHU de Bordeaux Pessac
France Centre hospitalier Lyon Sud Pierre-benite
France CHU de Pointe à Pitre Pointe À Pitre
France CHU de Poitiers Poitiers
France CHU de Reims Reims
France CHU de Rennes Rennes
France CHU de Rouen Rouen
France CHU de Strasbourg Strasbourg
France CHU de Toulouse - Larrey Toulouse
France CHU de Tours Tours
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and natural history of the 3 types of rare skin cancers 10 years
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