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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02100111

Enrollment

134

Registered

2014-03-31

Start date

2005-01-01

Completion date

2011-12-31

Last updated

2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France, Germany, Italy, United Kingdom

Outcome results