Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 9:20 AM
Study NCT ID:
NCT03210935
Status:
RECRUITING
Last Update Posted:
2021-03-09
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French National Database of Rare Dermatological Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}], 'ancestors': [{'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2017-07-04', 'studyFirstSubmitQcDate': '2017-07-04', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and natural history of the 3 types of rare skin cancers', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adnexal cutaneous carcinoma', 'Merkel cell carcinoma', 'Advanced basal cell carcinoma requiring systemic treatment'], 'conditions': ['Adnexal Tumor of Skin', 'Merkel Cell Carcinoma', 'Advanced Basal Cell Carcinoma Requiring Systemic Treatment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.caraderm.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nCARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are :\n\n* to provide epidemiological, clinical and socio-economic characteristics of patients\n* to identify new clinical or epidemiological prognostic factors for these rare cancers\n* to evaluate the impact of various treatments on outcomes', 'detailedDescription': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma\n\nExclusion Criteria:\n\n* Subjects without Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, or cutaneous adnexal carcinoma\n* Patients refusal'}, 'identificationModule': {'nctId': 'NCT03210935', 'acronym': 'CARADERM', 'briefTitle': 'French National Database of Rare Dermatological Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas', 'orgStudyIdInfo': {'id': 'NI_2014_60'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Merkel cell carcinoma'}, {'label': 'Advanced basal cell carcinoma'}, {'label': 'Cutaneous adnexal carcinomas'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Lok, MD', 'role': 'CONTACT'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ludovic Martin, MD', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Annecy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie De Quatrebarbes, MD', 'role': 'CONTACT'}], 'facility': 'CH Annecy Gennevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Aubin, MD', 'role': 'CONTACT'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eve Maubec, MD', 'role': 'CONTACT'}], 'facility': 'CHU Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Boulogne-Billancourt', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Saiag, MD', 'role': 'CONTACT'}], 'facility': 'CHU Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Misery, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence VERNEUIL, MD, PhD', 'role': 'CONTACT'}, {'name': 'Laurence VERNEUIL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': "Michel d'Incan, MD", 'role': 'CONTACT'}], 'facility': 'CHU de Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'sophie DALAC, md', 'role': 'CONTACT', 'email': 'sophie.dalac@chu-dijon.fr', 'phone': '03 80 29 33 36'}], 'facility': 'CHU Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Therese Leccia, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie BENETON-BENHARD, md', 'role': 'CONTACT', 'email': 'nbeneton@ch-lemans.fr', 'phone': '02 43 43 43 58'}], 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Bedane, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick Combemasle, MD', 'role': 'CONTACT'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Jacques Grob, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bernard Guillot, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital St Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence Granel-Brocard, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte DRENO, MD, PhD', 'role': 'CONTACT'}, {'name': 'Brigitte DRENO, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Nantes - Place Alexis Ricordeau', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Philippe Lacour, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guido Bens, MD', 'role': 'CONTACT'}], 'facility': "CHR d'Orleans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent Descamps, MD', 'role': 'CONTACT'}], 'facility': 'CHU Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Selim Aractingi, MD', 'role': 'CONTACT'}], 'facility': 'CHU Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Celeste Lebbe, MD', 'role': 'CONTACT'}], 'facility': 'CHU St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie BEYLOT-BARRY, MD, PhD', 'role': 'CONTACT'}, {'name': 'Marie BEYLOT-BARRY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'luc THOMAS, md,phd', 'role': 'CONTACT', 'email': 'luc.thomas@chu-lyon.fr', 'phone': '04 78 86 16 79'}], 'facility': 'Centre hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Pointe à Pitre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nadège Cordel, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Pointe à Pitre', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gerard Guillet, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florent Grange, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain Dupuy', 'role': 'CONTACT'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal JOLY, MD, PhD', 'role': 'CONTACT'}, {'name': 'Pascal JOLY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dan Lipsker, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas MEYER, MD, PhD', 'role': 'CONTACT'}, {'name': 'Nicolas MEYER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Toulouse - Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Machet, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline ROBERT, MD, PhD', 'role': 'CONTACT'}, {'name': 'Caroline ROBERT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Laurent MORTIER, MD,PhD', 'role': 'CONTACT', 'email': 'laurent.mortier@chru-lille.fr', 'phone': '03.20.44.41.93', 'phoneExt': '+33'}, {'name': 'Benoit Minart', 'role': 'CONTACT', 'email': 'benoit.minart@chru-lille.fr'}], 'overallOfficials': [{'name': 'Laurent MORTIER, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}