A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated… (NCT07649252) | Clinical Trial Compass
CompletedNot Applicable
A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan
Japan82 participantsStarted 2022-08-01
Plain-language summary
The aim of this study was to describe the patient profile and treatment patterns of adult melanoma patients that were treated with either dabrafenib and trametinib (Dab+Tram) or encorafenib and binimetinib (Enco+Bini) between 01 January 2012 and 30 November 2021 in Japan.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
All patients who met all of the following criteria were included:
* Had a confirmed diagnosis of melanoma recorded during the identification period, and
* Had at least 6 months of enrollment before the index date A, where index date A was defined as the first date of a confirmed diagnosis of melanoma recorded during the identification period, and
* Were at least 18 years old at the time of initiation of the first line of treatment (LoT).
The Adjuvant Dab+Tram Cohort included all patients who met all of the following criteria:
* Satisfied all of the general inclusion criteria, and
* Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and
* Had at least 6 months of follow-up after the index date B, where index B was defined as the first date of a prescription recorded at or after index date A, and
* Had the first dabrafenib or trametinib prescription claim recorded within 12 weeks of an excision surgery, and
* Did not have a confirmed metastasis diagnosis recorded within 1 month before, at, or within 12 weeks after the index date A.
The Non-adjuvant Dab+Tram Cohort included all patients that met all of the following criteria:
* Satisfied all of the general inclusion criteria, and
* Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and
* Had at least 6 months of follow-up after the index date B, and
* Not included in the Adjuvant Dab+T…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Age at Date of Treatment Initiation
Timeframe: Throughout the study identification period, approximately 9 years, 6 months
2
Number of Patients by Clinical Characteristics at the Date of Treatment Initiation
Timeframe: Throughout the study identification period, approximately 9 years, 6 months
3
Weight at Date of Treatment Initiation
Timeframe: Throughout the study identification period, approximately 9 years, 6 months
4
Height at Date of Treatment Initiation
Timeframe: Throughout the study identification period, approximately 9 years, 6 months
5
BMI at Date of Treatment Initiation
Timeframe: Throughout the study identification period, approximately 9 years, 6 months
6
CCI Score at Date of Treatment Initiation
Timeframe: Throughout the study identification period, approximately 9 years, 6 months
7
Time From Diagnosis to First Targeted Therapy Initiation