NCT03199846
Completed
Not Applicable
Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
ConditionsMelanoma
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Distribution of treatment patterns for advanced melanoma patients
Overview
Brief Summary
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 18 years or older
- •Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
- •Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
- •Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Exclusion Criteria
- •Physicians unwilling or unable to follow study instructions
- •Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
Outcomes
Primary Outcomes
Distribution of treatment patterns for advanced melanoma patients
Time Frame: Aproximately 6 months
Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy
Secondary Outcomes
- Distribution of prescribing patterns(Approximately 16 months)
- Distribution of Patient Age at index date(at baseline)
- Distribution of Patient's Sex at Index Date(At Baseline)
- Distribution of Comorbidities at index date(At Baseline)
- Distribution of Healthcare Coverage type(At Baseline)
- Distribution of Diagnosis Date(At Baseline)
- Distribution of Advanced Diagnosis Date(At Baseline)
- Distribution of Age at Onset(At Baseline)
- Distribution of Disease stage at time of diagnosis(At Baseline)
- Distribution of Disease stage at subsequent visits(Approximately 16 months)
- Distribution of ECOG status at Baseline(At Baseline)
- Distribution of ECOG status at Last Visit(Approximately 16 months)
- Distribution of Biomarker status at baseline(at baseline)
- Distribution of treatment-related adverse events(Approximately 16 months)
- Distribution of Overall Survival (OS) from Advanced Diagnosis(Approximately 16 months)
- Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis(Approximately 16 months)
- Distribution of Overall Response Rate (ORR)(Approximately 16 months)
- Distribution of Overall Survival (OS) from Index Date(Approximately 16 months)
- Distribution of Progression-Free Survival (PFS) at Index Date(Approximately 16 months)
- Distribution of melanoma related HCRU(Approximately 16 months)
Investigators
Study Sites (1)
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