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Completed

NCT Number: NCT02100111

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

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hotel Dieu; Dermatologie, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Participants Demographics: Age at Initation of Study

    Time frame: Baseline (Initiation of the study)

  2. Participants Demographics: Gender at Initation of Study

    Time frame: Baseline

  3. Participants Demographics: Race at Initation of Study

    Time frame: Baseline

  4. Participants Demographics: Country of Enrollment at Initation of Study

    Time frame: Baseline

  5. Percentage of Participants Categorized as per BCC Disease History

    Time frame: Baseline up to 9 months

  6. Percentage of Participants Categorized as per BCC Type

    Time frame: Baseline up to 9 months

  7. Percentage of Participants Categorized as per Site of Primary Lesion

    Time frame: Baseline up to 9 months

  8. Percentage of Participants Categorized as per Number of Lesions

    Time frame: Baseline up to 9 months

  9. Percentage of Participants Categorized as per Size of Lesions

    Time frame: Baseline up to 9 months

  10. Percentage of Participants Categorized as per Histopathology of BCC

    Time frame: Baseline up to 9 months

  11. Percentage of Participants Categorized as per Basal Cell Carcinoma Nevus Syndrome (BCCNS) Status

    Time frame: Baseline up to 9 months

  12. Percentage of Participants Categorized as per Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: Baseline up to 9 months

  13. Percentage of Participants Categorized as per Number of Biopsies Undergone

    Time frame: Baseline up to 9 months

  14. Percentage of Participants Categorized as per Type of BCC Treatment Received

    Time frame: Baseline up to 9 months

  15. Percentage of Participants With Complete Response

    Time frame: Baseline up to 9 months

  16. Percentage of Participants With Partial Response

    Time frame: Baseline up to 9 months

  17. Percentage of Participants With Stable Disease

    Time frame: Baseline up to 9 months

  18. Percentage of Participants With Disease Progression

    Time frame: Baseline up to 9 months

  19. Percentage of Participants Who Died

    Time frame: Baseline up to event of death assessed maximum up to 9 months

  20. Percentage of Participants With Progression Free survival

    Time frame: Baseline up to 9 months

  21. Percentage of Participants Categorized as per Impact of Surgery for BCC on Organ Function

    Time frame: Baseline up to 9 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2014
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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