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Completed

NCT Number: NCT06369428

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

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.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021

    Time frame: Up to approximately 7 years

  2. Point Prevalence per 100,000 Population

    Time frame: Up to approximately 7 years

    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).

  3. Mean Age of Patients at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  4. Mean Length of Follow-up at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  5. Gender at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  6. Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  7. Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  8. Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  9. Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  10. Number of Patients with Negative BRAF Status at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  11. Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

    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).

  12. Number of Patients by Number of Metastatic Organs at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  13. Number of Patients by Location of Metastases at Index Date per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

    Locations of metastatic sites at study entry:

    • lymph node
    • lung
    • skin/subcutaneous
    • liver
    • brain
    • bone
    • kidney
    • peritoneum/peritoneal cavity
    • spleen
    • pancreas
    • intestine

  14. Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District

    Time frame: Index date, defined as date of metastasis diagnosis

  15. Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication

    Time frame: 5 years prior to index date, where index date was defined as date of metastasis diagnosis

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 7 years

    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.

  2. Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment

    Time frame: Up to approximately 7 years

    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.

  3. Duration of Treatment (DoT)

    Time frame: Up to approximately 7 years

    DoT was defined as the time from initiation of a treatment line until the end of treatment, death, or end of study follow-up.

  4. Mean Age at Index Date per First-line (1L) Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  5. Length of Follow-up at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  6. Time to Treatment at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  7. Gender at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  8. Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  9. Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  10. Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  11. Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  12. Number of Patients with Negative BRAF Status at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  13. Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

    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).

  14. Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  15. Number of Patients by Location of Metastases at Index Date per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

    Locations of metastatic sites at study entry:

    • lymph node
    • lung
    • skin/subcutaneous
    • liver
    • brain
    • bone
    • kidney
    • peritoneum/peritoneal cavity
    • spleen
    • pancreas
    • intestine

  16. Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication

    Time frame: Index date, defined as date of metastasis diagnosis

  17. Number of Patients that Received Radiotherapy During 1L Treatment

    Time frame: Index date, defined as date of metastasis diagnosis

  18. Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment

    Time frame: Up to approximately 7 years

  19. Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment

    Time frame: Up to approximately 7 years

  20. Number of Patients Switched from TT 1L Treatment to IO 2L Treatment

    Time frame: Up to approximately 7 years

  21. Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment

    Time frame: Up to approximately 7 years

  22. Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment

    Time frame: Up to approximately 7 years

  23. Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment

    Time frame: Up to approximately 7 years

  24. Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment

    Time frame: Up to approximately 7 years

  25. Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment

    Time frame: Up to approximately 7 years

  26. Number of Patients Switched from TT 2L Treatment to IO 3L Treatment

    Time frame: Up to approximately 7 years

  27. Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment

    Time frame: Up to approximately 7 years

  28. Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment

    Time frame: Up to approximately 7 years

  29. Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment

    Time frame: Up to approximately 7 years

  30. Number of Healthcare Contacts and Associated Costs per Patient Year

    Time frame: Up to approximately 7 years

    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.

  31. Number of Healthcare Contacts and Associated Costs per Patient

    Time frame: Up to approximately 7 years

    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.

  32. Number of Healthcare Contacts and Associated Total Costs

    Time frame: Up to approximately 7 years

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

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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