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Interferon Toxicities in Melanoma Treatment (ITMT)

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ClinicalTrials.gov Identifier: NCT02794636
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.

Condition or disease
Stage III Melanoma

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Study Type : Observational
Actual Enrollment : 436 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma
Study Start Date : May 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort
IFN Treatment
Adult (age ≥ 18 years) patients identified as having stage III melanoma and no other primary or secondary cancer who initiated treatment with IFN between 1/1/2007 and 12/31/2011. Patients are required to have continuous pharmaceutical benefit enrollment for 180 days before (pre-index) and after (post-index) IFN initiation and no evidence of treatment with systemic chemotherapy during the pre- or post-index period



Primary Outcome Measures :
  1. Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy [ Time Frame: 180 days prior to the index date ]
  2. Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy [ Time Frame: 180 days after the index date ]
  3. Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy [ Time Frame: 180 days prior to the index date ]
  4. Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy [ Time Frame: 180 days after the index date ]
  5. Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy [ Time Frame: 180 days prior to the index date ]
  6. Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy [ Time Frame: 180 days after the index date ]

Secondary Outcome Measures :
  1. Pre-IFN treatment period Health care costs related to depression [ Time Frame: 180 days prior to the index date ]
  2. Post-IFN treatment period Health care costs related to depression [ Time Frame: 180 days after the index date ]
  3. Pre-IFN treatment period Health care costs related to fatigue [ Time Frame: 180 days prior to the index date ]
  4. Post-IFN treatment period Health care costs related to fatigue [ Time Frame: 180 days after the index date ]
  5. Pre-IFN treatment period Health care costs related to myalgia [ Time Frame: 180 days prior to the index date ]
  6. Post-IFN treatment period Health care costs related to myalgia [ Time Frame: 180 days after the index date ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Health plan enrollees whose data are reflected in the Truven Health MarketScan Commercial and Medicare Supplemental database. This database captures clinical utilization, expenditures and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations
Criteria

Inclusion Criteria:

  • Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
  • Patients with a melanoma diagnosis based on two medical claims prior to the index date
  • Patients with a procedure code for melanoma-related lymph node dissection before the index date
  • Patients ≥ 18 years of age on or before the index date
  • Patients with continuous benefit enrollment for at least 180 days before and after the index date

Exclusion Criteria:

  • Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
  • Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
  • Patients who received systemic chemotherapy during the pre- or post-index period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794636


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02794636    
Other Study ID Numbers: CA184-404
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas