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

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

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.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Hotel Dieu; Dermatologie
  • Antony, France, 92166
    • Hopital Prive D Antony; Dermatologie
  • Besançon, France, 25000
    • Hôpital St Jacques de Besançon; (Dermatology)
  • Bordeaux, France, 33075
    • Hopital Saint Andre CHU De Bordeaux; Dermatologie
  • Boulogne-billancourt, France, 92100
    • Hopital Ambroise Pare; Sce Dermatologie
  • Brest, France, 29609
    • Hopital La Cavale Blanche; Medecine 1
  • Clermont Ferrand, France, 63003
    • Chu Estaing; Dermatologie
  • Dreux, France, 28102
    • Hopital Victor Jousselin; Dermatologie
  • Epinal, France, 88021
    • Chi Emile Durkheim Site Epinal; Oncologie
  • Grenoble, France, 38043
    • Hôpital Albert Michallon; Derm Phlebologie Allergologie
  • Lille, France, 59037
    • Hopital Claude Huriez; Sce Dermatologie
  • Lille, France, 59020
    • Hopital Saint Vincent; Consult Dermatologie Enfants
  • Limoges, France, 87042
    • Hopital Dupuytren; Dermatologie
  • Marseille, France, 13385
    • Hopital Timone Adultes; Radiotherapie Oncologie
  • Montivilliers, France, 76290
    • Hopital Jacques Monod; Dermatologie
  • Montpellier, France, 34295
    • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
  • Paris, France, 75475
    • Hopital Saint Louis; Dermatologie 1
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard; Sce Dermatologie
  • Pessac, France, 33600
    • Hopital de Haut-Leveque; Dermatologie Serv.
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud; Dermatologie
  • Poitiers, France, 86021
    • Chu La Miletrie; Dermatologie
  • Quimper, France, 29000
    • Hopital Laennec; Sce Dermatologie
  • Saint-Etienne, France, 42277
    • Hopital Nord ; Dermatologie
  • Salouel, France, 80480
    • Hopital Sud; Dermatologie
  • Vandoeuvre Les Nancy, France, 54511
    • Hopitaux de Brabois; Dermatologie
• Germany
  • Erfurt, Germany, 99089
    • HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
  • Frankfurt, Germany, 60590
    • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
  • Mannheim, Germany, 68167
    • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
  • München, Germany, 80337
    • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
  • Quedlinburg, Germany, 06484
    • Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
• Italy
  • Basilicata
    • Rionero in Vulture, Basilicata, Italy, 85028
      • Irccs Crob
  • Emilia-Romagna
    • Reggio Emilia, Emilia-Romagna, Italy, 42123
      • Arcispedale Santa Maria Nuova; Dermatologia
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Spedali Civili di Brescia
  • Piemonte
    • Novara, Piemonte, Italy, 28100
      • Università del Piemonte Orientale; Dipartimento di Dermatologia
    • Torino, Piemonte, Italy, 10126
      • Policlinico Le Molinette; Clinica Dermatologica
  • Toscana
    • Firenze, Toscana, Italy, 50125
      • Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica
    • Siena, Toscana, Italy, 53100
      • A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
• United Kingdom
  • Glasgow, United Kingdom, G11 6NT
    • Western Infirmary; Division of Cardiovascular and Medical Sciences
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary; Department Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with locally advanced or metastatic BCC

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with advanced or metastatic BCC; Participants with BCC who received any treatment including surgeries, radiation, photodynamic therapy, chemotherapy, supportive/palliative care, or other therapies, will be included as a part of study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participants Demographics: Age at Initation of Study	Baseline (Initiation of the study)
Participants Demographics: Gender at Initation of Study	Baseline
Participants Demographics: Race at Initation of Study	Baseline
Participants Demographics: Country of Enrollment at Initation of Study	Baseline
Percentage of Participants Categorized as per BCC Disease History	Baseline up to 9 months
Percentage of Participants Categorized as per BCC Type	Baseline up to 9 months
Percentage of Participants Categorized as per Site of Primary Lesion	Baseline up to 9 months
Percentage of Participants Categorized as per Number of Lesions	Baseline up to 9 months
Percentage of Participants Categorized as per Size of Lesions	Baseline up to 9 months
Percentage of Participants Categorized as per Histopathology of BCC	Baseline up to 9 months
Percentage of Participants Categorized as per Basal Cell Carcinoma Nevus Syndrome (BCCNS) Status	Baseline up to 9 months
Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status	Baseline up to 9 months
Percentage of Participants Categorized as per Number of Biopsies Undergone	Baseline up to 9 months
Percentage of Participants Categorized as per Type of BCC Treatment Received	Baseline up to 9 months
Percentage of Participants With Complete Response	Baseline up to 9 months
Percentage of Participants With Partial Response	Baseline up to 9 months
Percentage of Participants With Stable Disease	Baseline up to 9 months
Percentage of Participants With Disease Progression	Baseline up to 9 months
Percentage of Participants Who Died	Baseline up to event of death assessed maximum up to 9 months
Percentage of Participants With Progression Free survival	Baseline up to 9 months
Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function	Baseline up to 9 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): December 31, 2011
• Study Completion (Actual): December 31, 2011

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: MO28682

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No