Interferon Toxicities in Melanoma Treatment

NCT02794636 | Completed

• 1 other identifier: CA184-404
• Study Type: observational
• Target: 436
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage III Melanoma

Outcome Measures

Primary Outcomes (6)

• Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy

  180 days prior to the index date

• Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy

  180 days after the index date

• Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy

  180 days prior to the index date

• Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy

  180 days after the index date

• Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy

  180 days prior to the index date

• Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy

  180 days after the index date

Secondary Outcomes (6)

• Pre-IFN treatment period Health care costs related to depression

  180 days prior to the index date

• Post-IFN treatment period Health care costs related to depression

  180 days after the index date

• Pre-IFN treatment period Health care costs related to fatigue

  180 days prior to the index date

• Post-IFN treatment period Health care costs related to fatigue

  180 days after the index date

• Pre-IFN treatment period Health care costs related to myalgia

  180 days prior to the index date

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 9, 2016

Record last verified: 2016-06