Last updated: 02/04/2020 15:20:06
The epidemiology, management patterns, and direct costs of treating malignant melanoma: a retrospective and prospective observational survey using the Canadian Melanoma Research Network (CMRN) Patient Registry
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: The epidemiology, management patterns, and direct costs of treating malignant melanoma: a retrospective and prospective observational survey using the Canadian Melanoma Research Network (CMRN) Patient Registry
Trial description: This is a Canadian multicentre, observational, prospective and retrospective study of patients with malignant melanoma, with all data collected via the Canadian Melanoma Research Network (CMRN) Patient Registry. Using the Canadian Melanoma Research Network Patient Registry, we aim (1) to study the presentation, disease characteristics and course, and treatment patterns for malignant melanoma in Ontario; and (2) to estimate the resource utilization and costs associated with the management of these patients. All subjects will be patients being treated for cutaneous malignant melanoma (CMM) at one of the three participating health centres (London Health Science Centre, Princess Margret Hospital and Sunnybrook Health Sciences Centre) within the Canadian Melanoma Research Network, enrolled either retrospectively over the year prior to beginning prospective data entry (April 2011 – April 2012), or prospectively until April 30,2013. Resource utilization will include melanoma related hospitalizations, outpatient visits, ER visits, costs associated with management of AE's and palliative care. Other primary outcomes include, survival (alive or dead), disease status (stable or progressing, new or recurrent), treatments received.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Melanoma related healthcare resource utilization
Timeframe: 1 year
Melanoma related disease characteristics
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2014-24-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- All patients with confirmed melanoma seen at any one of the three participating treatment centers over either the retrospective or prospective duration of observation will be eligible for entry into the study database.
- Subjects with at least one year of follow-up will be eligible for analysis.
- Anyone for whom the diagnosis of melanoma has not been histologically confirmed, or for whom such information cannot be accessed, will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- All patients with confirmed melanoma seen at any one of the three participating treatment centers over either the retrospective or prospective duration of observation will be eligible for entry into the study database.
- Subjects with at least one year of follow-up will be eligible for analysis.
Exclusion criteria:
- Anyone for whom the diagnosis of melanoma has not been histologically confirmed, or for whom such information cannot be accessed, will be excluded.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2014-24-06
Actual study completion date
2014-24-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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