Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients

Metastatic Melanoma Clinical Trial

Official title:

Non-interventional Register-based Study to Analyze Patient Characteristics, Treatment Patterns and Healthcare Resource Utilization in Adult Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06369428
• Other study ID #: CDRB436BFI02
• Status: Completed
• Start date: June 23, 2021
• Est. completion date: April 13, 2023

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1795
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021		Up to approximately 7 years
Primary	Point Prevalence per 100,000 Population	Point prevalence was defined as the number of metastatic melanoma patients alive at the end of 2021 divided by the total of hospital districts of Helsinki and Uusimaa hospital district (HUS), Pirkanmaa hospital district (PSHP), and Hospital district of Southwest Finland (VSSHP).	Up to approximately 7 years
Primary	Mean Age of Patients at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Mean Length of Follow-up at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Gender at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients with Negative BRAF Status at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District	CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (=2).	Index date, defined as date of metastasis diagnosis
Primary	Number of Patients by Number of Metastatic Organs at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients by Location of Metastases at Index Date per Hospital District	Locations of metastatic sites at study entry: lymph node; lung; skin/subcutaneous; liver; brain; bone; kidney; peritoneum/peritoneal cavity; spleen; pancreas; intestine	Index date, defined as date of metastasis diagnosis
Primary	Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District		Index date, defined as date of metastasis diagnosis
Primary	Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication		5 years prior to index date, where index date was defined as date of metastasis diagnosis
Secondary	Overall Survival (OS)	Overall survival was defined as the time from the index date until death or to end of study follow-up. Index date was defined as date of metastasis diagnosis.	Up to approximately 7 years
Secondary	Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment	TTNT was defined as the time from initiation of a treatment line until the initiation of the next treatment line, death, or end of study follow-up.	Up to approximately 7 years
Secondary	Duration of Treatment (DoT)	DoT was defined as the time from initiation of a treatment line until the end of treatment, death, or end of study follow-up.	Up to approximately 7 years
Secondary	Mean Age at Index Date per First-line (1L) Medication		Index date, defined as date of metastasis diagnosis
Secondary	Length of Follow-up at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Time to Treatment at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Gender at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients with Negative BRAF Status at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication	CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (=2).	Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients by Location of Metastases at Index Date per 1L Medication	Locations of metastatic sites at study entry: lymph node; lung; skin/subcutaneous; liver; brain; bone; kidney; peritoneum/peritoneal cavity; spleen; pancreas; intestine	Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients that Received Radiotherapy During 1L Treatment		Index date, defined as date of metastasis diagnosis
Secondary	Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from TT 1L Treatment to IO 2L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from TT 2L Treatment to IO 3L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment		Up to approximately 7 years
Secondary	Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment		Up to approximately 7 years
Secondary	Number of Healthcare Contacts and Associated Costs per Patient Year	Costs of outpatient visits, hospitalizations, and emergency room (ER) visits were estimated using unit costs and thus contain an average cost of performed procedures and operations, analyzed laboratory tests, and given medications (i.e. hospital inpatient medications) during the healthcare contact.	Up to approximately 7 years
Secondary	Number of Healthcare Contacts and Associated Costs per Patient	Costs of outpatient visits, hospitalizations, and emergency room (ER) visits were estimated using unit costs and thus contain an average cost of performed procedures and operations, analyzed laboratory tests, and given medications (i.e. hospital inpatient medications) during the healthcare contact.	Up to approximately 7 years
Secondary	Number of Healthcare Contacts and Associated Total Costs	Costs of outpatient visits, hospitalizations, and emergency room (ER) visits were estimated using unit costs and thus contain an average cost of performed procedures and operations, analyzed laboratory tests, and given medications (i.e. hospital inpatient medications) during the healthcare contact.	Up to approximately 7 years