Basal Cell Carcinoma Clinical Trial
Official title:
RONNIE - A Multi-Center, Multi-National, Retrospective Medical Record Review to Describe Treatment Patterns and Outcomes for Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Verified date | June 2017 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This multi-center, observational study involves reviewing the medical records of approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until 31 December 2010. Participant records will be analyzed to identify participant characteristics, treatment patterns and clinical outcomes.
Status | Completed |
Enrollment | 134 |
Est. completion date | December 31, 2011 |
Est. primary completion date | December 31, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - New diagnosis of advanced BCC, defined as (1) locally advanced BCC (inoperable as determined by the site investigator or surgery contraindicated) with receipt of radiation therapy (unless radiation was contraindicated), or (2) metastatic BCC, from 01 January 2005 through 31 December 2010 Exclusion Criteria: - Participation in an interventional trial that dictated treatment during the study time period (01 January 2005 - 31 December 2010), or within 90 days prior to individual participant' study enrolment dates - Participants undergoing treatment with a Hedgehog pathway inhibitor |
Country | Name | City | State |
---|---|---|---|
France | Hotel Dieu; Dermatologie | Angers | |
France | Hopital Prive D Antony; Dermatologie | Antony | |
France | Hôpital St Jacques de Besançon; (Dermatology) | Besançon | |
France | Hopital Saint Andre CHU De Bordeaux; Dermatologie | Bordeaux | |
France | Hopital Ambroise Pare; Sce Dermatologie | Boulogne-billancourt | |
France | Hopital La Cavale Blanche; Medecine 1 | Brest | |
France | Chu Estaing; Dermatologie | Clermont Ferrand | |
France | Hopital Victor Jousselin; Dermatologie | Dreux | |
France | Chi Emile Durkheim Site Epinal; Oncologie | Epinal | |
France | Hôpital Albert Michallon; Derm Phlebologie Allergologie | Grenoble | |
France | Hopital Claude Huriez; Sce Dermatologie | Lille | |
France | Hopital Saint Vincent; Consult Dermatologie Enfants | Lille | |
France | Hopital Dupuytren; Dermatologie | Limoges | |
France | Hopital Timone Adultes; Radiotherapie Oncologie | Marseille | |
France | Hopital Jacques Monod; Dermatologie | Montivilliers | |
France | Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie | Montpellier | |
France | Hopital Bichat Claude Bernard; Sce Dermatologie | Paris | |
France | Hopital Saint Louis; Dermatologie 1 | Paris | |
France | Hopital de Haut-Leveque; Dermatologie Serv. | Pessac | |
France | Centre Hospitalier Lyon Sud; Dermatologie | Pierre Benite | |
France | Chu La Miletrie; Dermatologie | Poitiers | |
France | Hopital Laennec; Sce Dermatologie | Quimper | |
France | Hopital Nord ; Dermatologie | Saint-Etienne | |
France | Hopital Sud; Dermatologie | Salouel | |
France | Hopitaux de Brabois; Dermatologie | Vandoeuvre Les Nancy | |
Germany | HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie | Erfurt | |
Germany | Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie | Frankfurt | |
Germany | SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie | Gera | |
Germany | Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen | Greifswald | |
Germany | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik | Mainz | |
Germany | Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie | Mannheim | |
Germany | Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie | München | |
Germany | Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie | Quedlinburg | |
Italy | Spedali Civili di Brescia | Brescia | Lombardia |
Italy | Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica | Firenze | Toscana |
Italy | Università del Piemonte Orientale; Dipartimento di Dermatologia | Novara | Piemonte |
Italy | Arcispedale Santa Maria Nuova; Dermatologia | Reggio Emilia | Emilia-Romagna |
Italy | Irccs Crob | Rionero in Vulture | Basilicata |
Italy | A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche | Siena | Toscana |
Italy | Policlinico Le Molinette; Clinica Dermatologica | Torino | Piemonte |
United Kingdom | Western Infirmary; Division of Cardiovascular and Medical Sciences | Glasgow | |
United Kingdom | Manchester Royal Infirmary; Department Of Medicine | Manchester |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
France, Germany, Italy, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants Demographics: Age at Initation of Study | Baseline (Initiation of the study) | ||
Primary | Participants Demographics: Gender at Initation of Study | Baseline | ||
Primary | Participants Demographics: Race at Initation of Study | Baseline | ||
Primary | Participants Demographics: Country of Enrollment at Initation of Study | Baseline | ||
Primary | Percentage of Participants Categorized as per BCC Disease History | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per BCC Type | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Site of Primary Lesion | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Number of Lesions | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Size of Lesions | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Histopathology of BCC | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Basal Cell Carcinoma Nevus Syndrome (BCCNS) Status | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Number of Biopsies Undergone | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Type of BCC Treatment Received | Baseline up to 9 months | ||
Primary | Percentage of Participants With Complete Response | Baseline up to 9 months | ||
Primary | Percentage of Participants With Partial Response | Baseline up to 9 months | ||
Primary | Percentage of Participants With Stable Disease | Baseline up to 9 months | ||
Primary | Percentage of Participants With Disease Progression | Baseline up to 9 months | ||
Primary | Percentage of Participants Who Died | Baseline up to event of death assessed maximum up to 9 months | ||
Primary | Percentage of Participants With Progression Free survival | Baseline up to 9 months | ||
Primary | Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function | Baseline up to 9 months |
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