French National Database of Rare Dermatological Cancers (CARADERM)

March 8, 2021 updated by: University Hospital, Lille

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens Picardie
        • Contact:
          • Catherine Lok, MD
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Ludovic Martin, MD
      • Annecy, France
        • Recruiting
        • Ch Annecy Gennevois
        • Contact:
          • Julie De Quatrebarbes, MD
      • Besançon, France
        • Recruiting
        • CHU Besançon
        • Contact:
          • François Aubin, MD
      • Bobigny, France
        • Recruiting
        • CHU Avicenne
        • Contact:
          • Eve Maubec, MD
      • Boulogne-Billancourt, France
        • Recruiting
        • CHU Ambroise Pare
        • Contact:
          • Philippe Saiag, MD
      • Brest, France
        • Recruiting
        • CHU de Brest
        • Contact:
          • Laurent Misery, MD
      • Caen, France
        • Recruiting
        • CHU de Caen
        • Contact:
          • Laurence VERNEUIL, MD, PhD
        • Principal Investigator:
          • Laurence VERNEUIL, MD, PhD
      • Clermont Ferrand, France
        • Recruiting
        • CHU de Clermont Ferrand
        • Contact:
          • Michel d'Incan, MD
      • Dijon, France, 21079
      • Grenoble, France
        • Recruiting
        • Chu De Grenoble
        • Contact:
          • Marie-Therese Leccia, MD
      • Le Mans, France, 72037
        • Recruiting
        • CH Le Mans
        • Contact:
      • Limoges, France
        • Recruiting
        • Chu de Limoges
        • Contact:
          • Christophe Bedane, MD
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Patrick Combemasle, MD
      • Marseille, France
        • Recruiting
        • Hôpital La Timone
        • Contact:
          • Jean Jacques Grob, MD
      • Montpellier, France
        • Recruiting
        • Hôpital St Eloi
        • Contact:
          • Bernard Guillot, MD
      • Nancy, France
        • Recruiting
        • CHU de Nancy
        • Contact:
          • Florence Granel-Brocard, MD
      • Nantes, France
        • Recruiting
        • CHU Nantes - Place Alexis Ricordeau
        • Principal Investigator:
          • Brigitte DRENO, MD, PhD
        • Contact:
          • Brigitte DRENO, MD, PhD
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Contact:
          • Jean Philippe Lacour, MD
      • Orléans, France
        • Recruiting
        • CHR d'Orléans
        • Contact:
          • Guido Bens, MD
      • Paris, France
        • Recruiting
        • CHU Cochin
        • Contact:
          • Selim Aractingi, MD
      • Paris, France
        • Recruiting
        • CHU Bichat
        • Contact:
          • Vincent Descamps, MD
      • Paris, France
        • Recruiting
        • CHU St Louis
        • Contact:
          • Celeste Lebbe, MD
      • Pessac, France
        • Recruiting
        • CHU de Bordeaux
        • Contact:
          • Marie BEYLOT-BARRY, MD, PhD
        • Principal Investigator:
          • Marie BEYLOT-BARRY, MD, PhD
      • Pierre-benite, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
      • Pointe À Pitre, France
        • Recruiting
        • CHU de Pointe à Pitre
        • Contact:
          • Nadège Cordel, MD
      • Poitiers, France
        • Recruiting
        • CHU de Poitiers
        • Contact:
          • Gerard Guillet, MD
      • Reims, France
        • Recruiting
        • CHU de Reims
        • Contact:
          • Florent Grange, MD
      • Rennes, France
        • Recruiting
        • CHU de Rennes
        • Contact:
          • Alain Dupuy
      • Rouen, France
        • Recruiting
        • Chu de Rouen
        • Contact:
          • Pascal JOLY, MD, PhD
        • Principal Investigator:
          • Pascal JOLY, MD, PhD
      • Strasbourg, France
        • Recruiting
        • CHU de Strasbourg
        • Contact:
          • Dan Lipsker, MD
      • Toulouse, France
        • Recruiting
        • CHU de Toulouse - Larrey
        • Principal Investigator:
          • Nicolas MEYER, MD, PhD
        • Contact:
          • Nicolas MEYER, MD, PhD
      • Tours, France
        • Recruiting
        • CHU de Tours
        • Contact:
          • Laurent Machet, MD
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Caroline ROBERT, MD, PhD
        • Contact:
          • Caroline Robert, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Merkel cell carcinoma
Advanced basal cell carcinoma
Cutaneous adnexal carcinomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and natural history of the 3 types of rare skin cancers
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2015

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI_2014_60

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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