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NCT01480219 Clinical Trial

Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g

Non-Melanoma Skin Carcinoma Clinical Trial

Official title:
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01480219
Other study ID # A1501098
Secondary ID
Status Completed
Phase N/A
First received November 23, 2011
Last updated February 4, 2013
Start date August 2011
Est. completion date March 2012

Study information
Verified date February 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung transplant and were continuously enrolled in a large U.S. commercial health plan.

Description:

N/A. All patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database were sampled.

Recruitment information / eligibility
Status Completed
Enrollment 467
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients aged 18 or older who received a lung or heart/lung transplant from January 1, 2002 through December 31, 2009 in the MarketScan database will be initially included in the study.

Exclusion Criteria:

- Patients who are younger than 18 years of age and who are not enrolled for at least 180 days before and 180 days after the date of transplant will be excluded.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• voriconazole (Vfend)
Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
Other:
• no voriconazole (Vfend)
Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Pfizer University of Southern California

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC) Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8 Yes

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