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French National Database of Rare Dermatological Cancers (CARADERM)

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ClinicalTrials.gov Identifier: NCT03210935
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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

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.


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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


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



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


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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

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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France
CHU Amiens Picardie Recruiting
Amiens, France
Contact: Catherine Lok, MD         
CHU Angers Recruiting
Angers, France
Contact: Ludovic Martin, MD         
CH Annecy Gennevois Recruiting
Annecy, France
Contact: Julie De Quatrebarbes, MD         
CHU Besançon Recruiting
Besançon, France
Contact: François Aubin, MD         
CHU Avicenne Recruiting
Bobigny, France
Contact: Eve Maubec, MD         
CHU Ambroise Paré Recruiting
Boulogne-Billancourt, France
Contact: Philippe Saiag, MD         
CHU de Brest Recruiting
Brest, France
Contact: Laurent Misery, MD         
CHU de Caen Recruiting
Caen, France
Contact: Laurence VERNEUIL, MD, PhD         
Principal Investigator: Laurence VERNEUIL, MD, PhD         
CHU de Clermont Ferrand Recruiting
Clermont Ferrand, France
Contact: Michel d'Incan, MD         
CHU Bocage Recruiting
Dijon, France, 21079
Contact: sophie DALAC, md    03 80 29 33 36    sophie.dalac@chu-dijon.fr   
CHU de Grenoble Recruiting
Grenoble, France
Contact: Marie-Therese Leccia, MD         
CH Le Mans Recruiting
Le Mans, France, 72037
Contact: Nathalie BENETON-BENHARD, md    02 43 43 43 58    nbeneton@ch-lemans.fr   
CHU de Limoges Recruiting
Limoges, France
Contact: Christophe Bedane, MD         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Patrick Combemasle, MD         
Hôpital La Timone Recruiting
Marseille, France
Contact: Jean Jacques Grob, MD         
Hôpital St Eloi Recruiting
Montpellier, France
Contact: Bernard Guillot, MD         
CHU de Nancy Recruiting
Nancy, France
Contact: Florence Granel-Brocard, MD         
CHU Nantes - Place Alexis Ricordeau Recruiting
Nantes, France
Contact: Brigitte DRENO, MD, PhD         
Principal Investigator: Brigitte DRENO, MD, PhD         
CHU de Nice Recruiting
Nice, France
Contact: Jean Philippe Lacour, MD         
CHR d'Orleans Recruiting
Orléans, France
Contact: Guido Bens, MD         
CHU Bichat Recruiting
Paris, France
Contact: Vincent Descamps, MD         
CHU Cochin Recruiting
Paris, France
Contact: Selim Aractingi, MD         
CHU St Louis Recruiting
Paris, France
Contact: Celeste Lebbe, MD         
CHU de Bordeaux Recruiting
Pessac, France
Contact: Marie BEYLOT-BARRY, MD, PhD         
Principal Investigator: Marie BEYLOT-BARRY, MD, PhD         
Centre hospitalier Lyon Sud Recruiting
Pierre-benite, France, 69495
Contact: luc THOMAS, md,phd    04 78 86 16 79    luc.thomas@chu-lyon.fr   
CHU de Pointe à Pitre Recruiting
Pointe À Pitre, France
Contact: Nadège Cordel, MD         
CHU de Poitiers Recruiting
Poitiers, France
Contact: Gerard Guillet, MD         
CHU de Reims Recruiting
Reims, France
Contact: Florent Grange, MD         
CHU de Rennes Recruiting
Rennes, France
Contact: Alain Dupuy         
CHU de Rouen Recruiting
Rouen, France
Contact: Pascal JOLY, MD, PhD         
Principal Investigator: Pascal JOLY, MD, PhD         
CHU de Strasbourg Recruiting
Strasbourg, France
Contact: Dan Lipsker, MD         
CHU de Toulouse - Larrey Recruiting
Toulouse, France
Contact: Nicolas MEYER, MD, PhD         
Principal Investigator: Nicolas MEYER, MD, PhD         
CHU de Tours Recruiting
Tours, France
Contact: Laurent Machet, MD         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Caroline ROBERT, MD, PhD         
Principal Investigator: Caroline ROBERT, MD, PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Laurent MORTIER, MD,PhD University Hospital, Lille

Additional Information:
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03210935     History of Changes
Other Study ID Numbers: NI_2014_60
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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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
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Neoplasms by Site
Skin Diseases
Dermatologic Agents