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Recruiting NCT03210935

French National Database of Rare Dermatological Cancers

Observational Adnexal Tumor of Skin Merkel Cell Carcinoma Advanced Basal Cell Carcinoma Requiring Systemic Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Adnexal Tumor of Skin, Merkel Cell Carcinoma, Advanced Basal Cell Carcinoma Requiring Systemic Treatment. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas

Overview

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.

Primary outcome measures

  • Incidence and natural history of the 3 types of rare skin cancers [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 34 centers
  • CHU Bocage — Dijon
  • CH Le Mans — Le Mans
  • Centre hospitalier Lyon Sud — Pierre-Bénite
  • CHU Amiens Picardie — Amiens
  • CHU Angers — Angers
  • CH Annecy Gennevois — Annecy
  • CHU Besançon — Besançon
  • CHU Avicenne — Bobigny
  • … and 26 more centers

Identifiers

NCT: NCT03210935 · NI_2014_60

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗