French National Database of Rare Dermatological Cancers

Recruiting

• Conditions: Merkel Cell Carcinoma; Adnexal Tumor of Skin; Advanced Basal Cell Carcinoma Requiring Systemic Treatment

• Registration Number: NCT03210935
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2015-11-24
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and natural history of the 3 types of rare skin cancers	10 years

Trial Locations

Locations (34)

CHU Amiens Picardie; 🇫🇷 Amiens, France

CHU Angers; 🇫🇷 Angers, France

CHU Bocage; 🇫🇷 Dijon, France

CHU Avicenne; 🇫🇷 Bobigny, France

CHU de Caen; 🇫🇷 Caen, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital St Eloi; 🇫🇷 Montpellier, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CHU Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

CHU de Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Hôpital La Timone; 🇫🇷 Marseille, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU Nantes - Place Alexis Ricordeau; 🇫🇷 Nantes, France

CHU de Nice; 🇫🇷 Nice, France

CHU de Toulouse - Larrey; 🇫🇷 Toulouse, France

CH Le Mans; 🇫🇷 Le Mans, France

CHR d'Orleans; 🇫🇷 Orléans, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Rouen; 🇫🇷 Rouen, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

CHU Bichat; 🇫🇷 Paris, France

CHU de Reims; 🇫🇷 Reims, France

CHU Besançon; 🇫🇷 Besançon, France

CH Annecy Gennevois; 🇫🇷 Annecy, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CHU de Pointe à Pitre; 🇫🇷 Pointe À Pitre, France

CHU de Tours; 🇫🇷 Tours, France

CHU Cochin; 🇫🇷 Paris, France

Centre hospitalier Lyon Sud; 🇫🇷 Pierre-benite, France

CHU de Bordeaux; 🇫🇷 Pessac, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Brest; 🇫🇷 Brest, France

CHU St Louis; 🇫🇷 Paris, France