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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02100111
Other study ID # MO28682
Secondary ID
Status Completed
Phase N/A
First received March 20, 2014
Last updated July 20, 2017
Start date January 1, 2005
Est. completion date December 31, 2011

Study information

Verified date June 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Germany,  Italy,  United Kingdom, 

Outcome

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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