Last updated: 02/04/2020 14:30:11

Understanding Current Patterns of Care and Planning for the Future – A Retrospective Observtional Study in Melanoma

GSK study ID
201376
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Understanding Current Patterns of Care and Planning for the Future – A Retrospective Observtional Study in Melanoma
Trial description: Melanoma, a malignant tumor of melanocytes found predominantly in the skin, causes the majority of skin cancer-related deaths. New therapies have been approved in the United States and more are being developed. Given the evolving landscape in the treatment of metastatic melanoma, GSK and Duke University Health System aim to conduct a retrospective, real-world observational study to inform the understanding of clinical practice patterns, treatment sequencing and prioritization, and patient experience.
The primary objective of this study is to describe treatment patterns in a population of subjects receiving care for metastatic melanoma in an academic oncology setting. The secondary objectives are 1.) to describe progression free survival (PFS) and tumor response and 2.) to describe health resource utilization (including office visits, concurrent medications including supportive care medications, hospitalization stays, and emergency department (ED) visits, and home health visits) in this population.
This study will be a retrospective analysis of data integrated from several Duke University Health System resources including the Duke Decision Support Repository which encompasses the Duke Tumor Registry, the Duke ePRO dataset, and Duke University Health System medical records. Data will be derived from these sources, with a unifying case report form (CRF). Data will be entered using an electronic data capture interface that mimics the CRF.
The design of this study is a retrospective observational study of melanoma patients treated at Duke University Health System.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Describe the treatment patterns

Timeframe: 30 months

Secondary outcomes:

Resource Utilization

Timeframe: 30 months

Response to Treatment

Timeframe: 30 months

Interventions:
  • Drug: trametinib
  • Drug: ipilimumab
  • Drug: peginterferon alfa-2b
  • Drug: dacarbazine
  • Drug: recombinant interferon alfa-2b
  • Drug: dabrafenib
  • Drug: vemurafenib
    • Enrollment:
    0
    Primary completion date:
    2014-31-12
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma
    Product
    dabrafenib, dabrafenib/trametinib, trametinib
    Collaborators
    Duke University
    Study date(s)
    March 2014 to December 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Age at least 18 years
    • Received some portion of their care from a medical oncologist with the Duke University Health System between June 30, 2009 and December 31, 2012
    • A primary malignancy other than melanoma during the 6 months prior to the index date or during course of care
    • Subjects who are pregnant during baseline or follow-up periods
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Age at least 18 years
    • Received some portion of their care from a medical oncologist with the Duke University Health System between June 30, 2009 and December 31, 2012
    • At least one diagnosis of melanoma: International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) code 172.x (malignant melanoma of the skin)
    • At least one diagnosis of Stage IIIC or Stage IV melanoma between January 1, 2010 and June 1, 2012 (Index Date) as indicated by TNM stage classification and confirmed in the electronic medical record. The end date assumes initiation of data collection no earlier than January 1,2010, and guarantees a minimum of 6 months follow-up within the medical record for all patients.
    • 6 months of follow up within the Duke system following Stage IIIC-IV diagnosis
    • Subjects who have died or are lost to follow up within the 6-month follow up period will be included in the study. (Subjects will be considered censored if not progressed.)
    Exclusion criteria:
    • A primary malignancy other than melanoma during the 6 months prior to the index date or during course of care
    • Subjects who are pregnant during baseline or follow-up periods

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    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
    2014-31-12
    Actual study completion date
    2014-31-12

    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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