Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007333

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This multi-center, observational study involves reviewing the medical records of
approximately 100 adult patients diagnosed with advanced BCC from 01 January 20 05 until 31
December 2010. All patients will be followed for a minimum of 1 year Patient records will be
analyzed to identify patient characteristics, treatmen t patterns and clinical outcomes.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007333
  •   2016/03/04
  •   2014/03/20
  •   no
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Secondary IDs

  •   NCT02100111  (ClinicalTrials.gov)
  •   MO28682  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Basal Cell Carcinoma
  •   C44 -  Other malignant neoplasms of skin
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Patient demographics (e.g., age, sex, race/ethnicity, nationality); time frame: 10 months
- BCC disease history for each patient (e.g. age at diagnosis, family history, risk factors); time frame: 10 months
- BCC disease characteristics for each patient (e.g. type, site/number/size of tumors, histopathology, etc); time frame: 10 months
- BCC treatment history for each patient (e.g., type/dose/frequency/dates of treatment, treament outcome); time frame: 10 months

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Secondary Outcome

- Additional significant medical history for each patient; time frame: 10 months

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Countries of Recruitment

  •   France
  •   Germany
  •   Italy
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/10/31
  •   134
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age >/= 18 years

- 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

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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 patients' study enrollment dates

- Treatment with a Hedgehog pathway inhibitor

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2013/07/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.