Clinical trial NCT02100111: An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with locally advanced or metastatic BCC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participants Demographics: Age at Initation of Study
timeFrame: Baseline (Initiation of the study)
measure: Participants Demographics: Gender at Initation of Study
timeFrame: Baseline
measure: Participants Demographics: Race at Initation of Study
timeFrame: Baseline
measure: Participants Demographics: Country of Enrollment at Initation of Study
timeFrame: Baseline
measure: Percentage of Participants Categorized as per BCC Disease History
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per BCC Type
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Site of Primary Lesion
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Number of Lesions
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Size of Lesions
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Histopathology of BCC
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Basal Cell Carcinoma Nevus Syndrome (BCCNS) Status
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Number of Biopsies Undergone
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Type of BCC Treatment Received
timeFrame: Baseline up to 9 months
measure: Percentage of Participants With Complete Response
timeFrame: Baseline up to 9 months
measure: Percentage of Participants With Partial Response
timeFrame: Baseline up to 9 months
measure: Percentage of Participants With Stable Disease
timeFrame: Baseline up to 9 months
measure: Percentage of Participants With Disease Progression
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Who Died
timeFrame: Baseline up to event of death assessed maximum up to 9 months
measure: Percentage of Participants With Progression Free survival
timeFrame: Baseline up to 9 months
measure: Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function
timeFrame: Baseline up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Hotel Dieu; Dermatologie
city: Antony
country: France
facility: Hopital Prive D Antony; Dermatologie
city: Besançon
country: France
facility: Hôpital St Jacques de Besançon; (Dermatology)
city: Bordeaux
country: France
facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie
city: Boulogne-billancourt
country: France
facility: Hopital Ambroise Pare; Sce Dermatologie
city: Brest
country: France
facility: Hopital La Cavale Blanche; Medecine 1
city: Clermont Ferrand
country: France
facility: Chu Estaing; Dermatologie
city: Dreux
country: France
facility: Hopital Victor Jousselin; Dermatologie
city: Epinal
country: France
facility: Chi Emile Durkheim Site Epinal; Oncologie
city: Grenoble
country: France
facility: Hôpital Albert Michallon; Derm Phlebologie Allergologie
city: Lille
country: France
facility: Hopital Saint Vincent; Consult Dermatologie Enfants
city: Lille
country: France
facility: Hopital Claude Huriez; Sce Dermatologie
city: Limoges
country: France
facility: Hopital Dupuytren; Dermatologie
city: Marseille
country: France
facility: Hopital Timone Adultes; Radiotherapie Oncologie
city: Montivilliers
country: France
facility: Hopital Jacques Monod; Dermatologie
city: Montpellier
country: France
facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
city: Paris
country: France
facility: Hopital Bichat Claude Bernard; Sce Dermatologie
city: Paris
country: France
facility: Hopital Saint Louis; Dermatologie 1
city: Pessac
country: France
facility: Hopital de Haut-Leveque; Dermatologie Serv.
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud; Dermatologie
city: Poitiers
country: France
facility: Chu La Miletrie; Dermatologie
city: Quimper
country: France
facility: Hopital Laennec; Sce Dermatologie
city: Saint-Etienne
country: France
facility: Hopital Nord ; Dermatologie
city: Salouel
country: France
facility: Hopital Sud; Dermatologie
city: Vandoeuvre Les Nancy
country: France
facility: Hopitaux de Brabois; Dermatologie
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
city: Mannheim
country: Germany
facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
city: München
country: Germany
facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
city: Rionero in Vulture
country: Italy
facility: Irccs Crob
state: Basilicata
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Dermatologia
state: Emilia-Romagna
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: Lombardia
city: Novara
country: Italy
facility: Università del Piemonte Orientale; Dipartimento di Dermatologia
state: Piemonte
city: Torino
country: Italy
facility: Policlinico Le Molinette; Clinica Dermatologica
state: Piemonte
city: Firenze
country: Italy
facility: Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica
state: Toscana
city: Siena
country: Italy
facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
state: Toscana
city: Glasgow
country: United Kingdom
facility: Western Infirmary; Division of Cardiovascular and Medical Sciences
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary; Department Of Medicine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: