Basal Cell CarcinomaNCT02100111
An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants
An observational study of Basal Cell Carcinoma, run by Hoffmann-La Roche at 42 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 134 participants
- Where
- 42 sitesin 4 countries
- Study dates
- 1 Jan 2005to 31 Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with locally advanced or metastatic BCC
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 4 countries.
42 sites in 4 countries
France25 sites
Hotel Dieu; Dermatologie
Angers, 49933
Hopital Prive D Antony; Dermatologie
Antony, 92166
Hôpital St Jacques de Besançon; (Dermatology)
Besançon, 25000
Hopital Saint Andre CHU De Bordeaux; Dermatologie
Bordeaux, 33075
Hopital Ambroise Pare; Sce Dermatologie
Boulogne-Billancourt, 92100
Hopital La Cavale Blanche; Medecine 1
Brest, 29609
Chu Estaing; Dermatologie
Clermont-Ferrand, 63003
Hopital Victor Jousselin; Dermatologie
Dreux, 28102
Chi Emile Durkheim Site Epinal; Oncologie
Épinal, 88021
Hôpital Albert Michallon; Derm Phlebologie Allergologie
Grenoble, 38043
Hopital Saint Vincent; Consult Dermatologie Enfants
Lille, 59020
Hopital Claude Huriez; Sce Dermatologie
Lille, 59037
Hopital Dupuytren; Dermatologie
Limoges, 87042
Hopital Timone Adultes; Radiotherapie Oncologie
Marseille, 13385
Hopital Jacques Monod; Dermatologie
Montivilliers, 76290
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
Montpellier, 34295
Hopital Bichat Claude Bernard; Sce Dermatologie
Paris, 75018
Hopital Saint Louis; Dermatologie 1
Paris, 75475
Hopital de Haut-Leveque; Dermatologie Serv.
Pessac, 33600
Centre Hospitalier Lyon Sud; Dermatologie
Pierre-Bénite, 69495
Chu La Miletrie; Dermatologie
Poitiers, 86021
Hopital Laennec; Sce Dermatologie
Quimper, 29000
Hopital Nord ; Dermatologie
Saint-Etienne, 42277
Hopital Sud; Dermatologie
Salouël, 80480
Hopitaux de Brabois; Dermatologie
Vandœuvre-lès-Nancy, 54511
Germany8 sites
HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
Erfurt, 99089
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, 60590
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera, 07548
Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen
Greifswald, 17475
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
Mainz, 55131
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
Mannheim, 68167
Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
München, 80337
Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
Quedlinburg, 06484
Italy7 sites
Spedali Civili di Brescia
Brescia, Lombardy, 25123
Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica
Florence, Tuscany, 50125
Università del Piemonte Orientale; Dipartimento di Dermatologia
Novara, Piedmont, 28100
Arcispedale Santa Maria Nuova; Dermatologia
Reggio Emilia, Emilia-Romagna, 42123
Irccs Crob
Rionero in Vulture, Basilicate, 85028
A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
Siena, Tuscany, 53100
Policlinico Le Molinette; Clinica Dermatologica
Turin, Piedmont, 10126
United Kingdom2 sites
Western Infirmary; Division of Cardiovascular and Medical Sciences
Glasgow, G11 6NT
Manchester Royal Infirmary; Department Of Medicine
Manchester, M13 9WL
About this study
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
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.
- Conditions
- Basal Cell Carcinoma
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Participants Demographics: Age at Initation of Study
Measured: Baseline (Initiation of the study)
Participants Demographics: Gender at Initation of Study
Measured: Baseline
Participants Demographics: Race at Initation of Study
Measured: Baseline
Participants Demographics: Country of Enrollment at Initation of Study
Measured: Baseline
Percentage of Participants Categorized as per BCC Disease History
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per BCC Type
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Site of Primary Lesion
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Number of Lesions
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Size of Lesions
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Histopathology of BCC
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Basal Cell Carcinoma Nevus Syndrome (BCCNS) Status
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Number of Biopsies Undergone
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Type of BCC Treatment Received
Measured: Baseline up to 9 months
Percentage of Participants With Complete Response
Measured: Baseline up to 9 months
Percentage of Participants With Partial Response
Measured: Baseline up to 9 months
Percentage of Participants With Stable Disease
Measured: Baseline up to 9 months
Percentage of Participants With Disease Progression
Measured: Baseline up to 9 months
Percentage of Participants Who Died
Measured: Baseline up to event of death assessed maximum up to 9 months
Percentage of Participants With Progression Free survival
Measured: Baseline up to 9 months
Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function
Measured: Baseline up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start1 Jan 2005
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100111
- Sponsor's protocol ID
- MO28682
- Status last verified
- Jun 2017
- First submitted
- 20 Mar 2014
- Last updated
- 24 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02100111
- Acronym / sponsor ID
- MO28682
- Conditions
- Basal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with locally advanced or metastatic BCC
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants Demographics: Age at Initation of Study
Time frame: Baseline (Initiation of the study)
Participants Demographics: Gender at Initation of Study
Time frame: Baseline
Participants Demographics: Race at Initation of Study
Time frame: Baseline
Participants Demographics: Country of Enrollment at Initation of Study
Time frame: Baseline
Percentage of Participants Categorized as per BCC Disease History
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per BCC Type
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per Site of Primary Lesion
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per Number of Lesions
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per Size of Lesions
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per Histopathology of BCC
Time frame: 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
Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per Number of Biopsies Undergone
Time frame: Baseline up to 9 months
Percentage of Participants Categorized as per Type of BCC Treatment Received
Time frame: Baseline up to 9 months
Percentage of Participants With Complete Response
Time frame: Baseline up to 9 months
Percentage of Participants With Partial Response
Time frame: Baseline up to 9 months
Percentage of Participants With Stable Disease
Time frame: Baseline up to 9 months
Percentage of Participants With Disease Progression
Time frame: Baseline up to 9 months
Percentage of Participants Who Died
Time frame: 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
Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function
Time frame: Baseline up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
42 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Hoffmann-La Roche at 42 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in France, Germany, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Demographics: Age at Initation of Study (time frame: Baseline (Initiation of the study)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.