An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100111
• Other study ID #: MO28682
• 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
• 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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

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