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

July 20, 2017 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Participants Demographics: Age at Initation of Study
Time Frame: Baseline (Initiation of the study)
Baseline (Initiation of the study)
Participants Demographics: Gender at Initation of Study
Time Frame: Baseline
Baseline
Participants Demographics: Race at Initation of Study
Time Frame: Baseline
Baseline
Participants Demographics: Country of Enrollment at Initation of Study
Time Frame: Baseline
Baseline
Percentage of Participants Categorized as per BCC Disease History
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per BCC Type
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Site of Primary Lesion
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Number of Lesions
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Size of Lesions
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Histopathology of BCC
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Basal Cell Carcinoma Nevus Syndrome (BCCNS) Status
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Number of Biopsies Undergone
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Type of BCC Treatment Received
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants With Complete Response
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants With Partial Response
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants With Stable Disease
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants With Disease Progression
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Who Died
Time Frame: Baseline up to event of death assessed maximum up to 9 months
Baseline up to event of death assessed maximum up to 9 months
Percentage of Participants With Progression Free survival
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function
Time Frame: Baseline up to 9 months
Baseline up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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