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French National Database of Rare Dermatological Cancers (CARADERM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210935
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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

Condition or disease
Adnexal Tumor of Skin Merkel Cell Carcinoma Advanced Basal Cell Carcinoma Requiring Systemic Treatment

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
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Study Type : Observational
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Merkel cell carcinoma
Advanced basal cell carcinoma
Cutaneous adnexal carcinomas


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and natural history of the 3 types of rare skin cancers [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210935


Contacts
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Contact: Laurent MORTIER, MD,PhD 03.20.44.41.93 ext +33 laurent.mortier@chru-lille.fr
Contact: Benoit Minart benoit.minart@chru-lille.fr

Locations
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Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Laurent MORTIER, MD,PhD University Hospital, Lille
More Information
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Additional Information:

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03210935    
Other Study ID Numbers: NI_2014_60
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Adnexal cutaneous carcinoma
Merkel cell carcinoma
Advanced basal cell carcinoma requiring systemic treatment
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Polyomavirus Infections
DNA Virus Infections
 Virus Diseases
Infections
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue