Metastatic MelanomaNCT06369428
Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients
An observational study of Metastatic Melanoma, run by Novartis at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- How many people
- 1,795 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jun 2021to 13 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Register-based Study to Analyze Patient Characteristics, Treatment Patterns and Healthcare Resource Utilization in Adult Patients With Metastatic Melanoma
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.
- Conditions
- Metastatic Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Distant Metastasis Cohort | Adult patients diagnosed with stage 4 (distant) metastatic melanoma between 2014 and 2021. | |
| Regional Metastasis Cohort | Adult patients diagnosed with stage 3 (regional) metastatic melanoma between 2014 and 2021. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021
Measured: Up to approximately 7 years
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).
Measured: Up to approximately 7 years
Mean Age of Patients at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Mean Length of Follow-up at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Gender at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with Negative BRAF Status at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
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).
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients by Number of Metastatic Organs at Index Date per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
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
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication
Measured: 5 years prior to index date, where index date was defined as date of metastasis diagnosis
Secondary outcomes (32)
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.
Measured: Up to approximately 7 years
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.
Measured: Up to approximately 7 years
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.
Measured: Up to approximately 7 years
Mean Age at Index Date per First-line (1L) Medication
Measured: Index date, defined as date of metastasis diagnosis
Length of Follow-up at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Time to Treatment at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Gender at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients with Negative BRAF Status at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
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).
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
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
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients that Received Radiotherapy During 1L Treatment
Measured: Index date, defined as date of metastasis diagnosis
Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from TT 1L Treatment to IO 2L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from TT 2L Treatment to IO 3L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment
Measured: Up to approximately 7 years
Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment
Measured: Up to approximately 7 years
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.
Measured: Up to approximately 7 years
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.
Measured: Up to approximately 7 years
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.
Measured: Up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start23 Jun 2021
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,795 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369428
- Sponsor's protocol ID
- CDRB436BFI02
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Register-based Study to Analyze Patient Characteristics, Treatment Patterns and Healthcare Resource Utilization in Adult Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT06369428
- Acronym / sponsor ID
- CDRB436BFI02
- Conditions
- Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,795 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distant Metastasis Cohort | – | –Adult patients diagnosed with stage 4 (distant) metastatic melanoma between 2014 and 2021. |
| Regional Metastasis Cohort | – | –Adult patients diagnosed with stage 3 (regional) metastatic melanoma between 2014 and 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021
Time frame: Up to approximately 7 years
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).
Mean Age of Patients at Index Date per Hospital District
Time frame: Index date, defined as date of metastasis diagnosis
Mean Length of Follow-up at Index Date per Hospital District
Time frame: Index date, defined as date of metastasis diagnosis
Gender at Index Date per Hospital District
Time frame: Index date, defined as date of metastasis diagnosis
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
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
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
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
Number of Patients with Negative BRAF Status at Index Date per Hospital District
Time frame: Index date, defined as date of metastasis diagnosis
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).
Number of Patients by Number of Metastatic Organs at Index Date per Hospital District
Time frame: Index date, defined as date of metastasis diagnosis
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
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District
Time frame: Index date, defined as date of metastasis diagnosis
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
32 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 7 years
Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment
Time frame: Up to approximately 7 years
Duration of Treatment (DoT)
Time frame: Up to approximately 7 years
Mean Age at Index Date per First-line (1L) Medication
Time frame: Index date, defined as date of metastasis diagnosis
Length of Follow-up at Index Date per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
Time to Treatment at Index Date per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
Gender at Index Date per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
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
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
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
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
Number of Patients with Negative BRAF Status at Index Date per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
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
Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
Number of Patients by Location of Metastases at Index Date per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication
Time frame: Index date, defined as date of metastasis diagnosis
Number of Patients that Received Radiotherapy During 1L Treatment
Time frame: Index date, defined as date of metastasis diagnosis
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
Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from TT 1L Treatment to IO 2L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from TT 2L Treatment to IO 3L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment
Time frame: Up to approximately 7 years
Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment
Time frame: Up to approximately 7 years
Number of Healthcare Contacts and Associated Costs per Patient Year
Time frame: Up to approximately 7 years
Number of Healthcare Contacts and Associated Costs per Patient
Time frame: Up to approximately 7 years
Number of Healthcare Contacts and Associated Total Costs
Time frame: Up to approximately 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by Novartis at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 (time frame: Up to approximately 7 years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.