Clinical trial NCT03199846: Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
Official title: Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of treatment patterns for advanced melanoma patients
timeFrame: Aproximately 6 months
Secondary outcomes:
measure: Distribution of prescribing patterns
timeFrame: Approximately 16 months
measure: Distribution of Patient Age at index date
timeFrame: at baseline
measure: Distribution of Patient's Sex at Index Date
timeFrame: At Baseline
measure: Distribution of Comorbidities at index date
timeFrame: At Baseline
measure: Distribution of Healthcare Coverage type
timeFrame: At Baseline
measure: Distribution of Diagnosis Date
timeFrame: At Baseline
measure: Distribution of Advanced Diagnosis Date
timeFrame: At Baseline
measure: Distribution of Age at Onset
timeFrame: At Baseline
measure: Distribution of Disease stage at time of diagnosis
timeFrame: At Baseline
measure: Distribution of Disease stage at subsequent visits
timeFrame: Approximately 16 months
measure: Distribution of ECOG status at Baseline
timeFrame: At Baseline
measure: Distribution of ECOG status at Last Visit
timeFrame: Approximately 16 months
measure: Distribution of Biomarker status at baseline
timeFrame: at baseline
measure: Distribution of treatment-related adverse events
timeFrame: Approximately 16 months
measure: Distribution of Overall Survival (OS) from Advanced Diagnosis
timeFrame: Approximately 16 months
measure: Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
timeFrame: Approximately 16 months
measure: Distribution of Overall Response Rate (ORR)
timeFrame: Approximately 16 months
measure: Distribution of Overall Survival (OS) from Index Date
timeFrame: Approximately 16 months
measure: Distribution of Progression-Free Survival (PFS) at Index Date
timeFrame: Approximately 16 months
measure: Distribution of melanoma related HCRU
timeFrame: Approximately 16 months
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: