Local Institution
Morristown, New Jersey, 07960, United States
Completed
NCT Number: NCT03199846
Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
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).
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Non-Interventional
OtherNon-Interventional
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
Time frame: Approximately 16 months
Distribution of prescribing patterns by type of practice setting and melanoma patient volume
-
Distribution of Patient Age at index date
Time frame: at baseline
Patient Age at index date will be determined from Medical Records
-
Distribution of Patient's Sex at Index Date
Time frame: At Baseline
Patient's sex will be determined from Medical Records
-
Distribution of Comorbidities at index date
Time frame: At Baseline
Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
-
Distribution of Healthcare Coverage type
Time frame: At Baseline
Healthcare Coverage type will be determined using Medical Records
-
Distribution of Diagnosis Date
Time frame: At Baseline
Melanoma Diagnosis Date will be determined using medical records
-
Distribution of Advanced Diagnosis Date
Time frame: At Baseline
Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
-
Distribution of Age at Onset
Time frame: At Baseline
Diagnosis date-Date of Birth
-
Distribution of Disease stage at time of diagnosis
Time frame: At Baseline
Disease stage at time of diagnosis will be determined using medical records
-
Distribution of Disease stage at subsequent visits
Time frame: Approximately 16 months
Disease stage at subsequent visits will be determined using medical records
-
Distribution of ECOG status at Baseline
Time frame: At Baseline
Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records
-
Distribution of ECOG status at Last Visit
Time frame: Approximately 16 months
Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records
-
Distribution of Biomarker status at baseline
Time frame: at baseline
Biomarker status will be determined using Medical Records
-
Distribution of treatment-related adverse events
Time frame: Approximately 16 months
treatment-related adverse events will be determined using medical records
-
Distribution of Overall Survival (OS) from Advanced Diagnosis
Time frame: Approximately 16 months
Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
-
Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
Time frame: Approximately 16 months
Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
-
Distribution of Overall Response Rate (ORR)
Time frame: Approximately 16 months
-
Distribution of Overall Survival (OS) from Index Date
Time frame: Approximately 16 months
Date of death minus index treatment start date, censoring for LTF or end of observation
-
Distribution of Progression-Free Survival (PFS) at Index Date
Time frame: Approximately 16 months
Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation
-
Distribution of melanoma related HCRU
Time frame: Approximately 16 months
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 27, 2017
- Registry last updated
- Feb 6, 2018
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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