Clinical trial NCT06369428: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients
Official title: Non-interventional Register-based Study to Analyze Patient Characteristics, Treatment Patterns and Healthcare Resource Utilization in Adult Patients With Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 1795
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: This was a retrospective, noninterventional cohort study.

Brief summary: This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district.


Eligibility criteria: Inclusion criteria

* Patients diagnosed with metastatic melanoma (C43) during 01 January 2014 and 31 December 2021.
* Adult (18 years or older) at the time of diagnosis of metastatic melanoma.
* Resident in the corresponding hospital district(s) at the time of diagnosis of metastatic melanoma.

Exclusion criteria

* Metastasis recorded prior to 01 January 2014 (i.e. prevalent case).
* Record of any other cancer (The International Classification of Diseases, 10th Revision \[ICD-10\] diagnosis code starting with C, excluding C43, C77, C78, and C79) as last cancer diagnosis before metastasis.
* Participated in COBRA (vemurafenib, temozolomide, lomustine, vincristine) trial.

Primary outcomes:
measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021
timeFrame: Up to approximately 7 years
measure: Point Prevalence per 100,000 Population
timeFrame: Up to approximately 7 years
measure: Mean Age of Patients at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Mean Length of Follow-up at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Gender at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Location of Metastases at Index Date per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication
timeFrame: 5 years prior to index date, where index date was defined as date of metastasis diagnosis
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 7 years
measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment
timeFrame: Up to approximately 7 years
measure: Duration of Treatment (DoT)
timeFrame: Up to approximately 7 years
measure: Mean Age at Index Date per First-line (1L) Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Length of Follow-up at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Time to Treatment at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Gender at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Location of Metastases at Index Date per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients that Received Radiotherapy During 1L Treatment
timeFrame: Index date, defined as date of metastasis diagnosis
measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment
timeFrame: Up to approximately 7 years
measure: Number of Healthcare Contacts and Associated Costs per Patient Year
timeFrame: Up to approximately 7 years
measure: Number of Healthcare Contacts and Associated Costs per Patient
timeFrame: Up to approximately 7 years
measure: Number of Healthcare Contacts and Associated Total Costs
timeFrame: Up to approximately 7 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
References: