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Clinical Trials/NCT03210935
NCT03210935RecruitingNot Applicable

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

University Hospital, Lille39 sites in 1 country9,000 target enrollmentStarted: November 24, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
9,000
Locations
39
Primary Endpoint
Incidence and natural history of the 3 types of rare skin cancers

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence and natural history of the 3 types of rare skin cancers

Time Frame: 10 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (39)

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