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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Basal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with advanced or metastatic BCC<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |