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Completed

NCT Number: NCT01480219

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

voriconazole (Vfend)

Drug

Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

Other names: Vfend

no voriconazole (Vfend)

Other

Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.

Other names: Vfend

Primary outcomes

  1. Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • University of Southern California

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2011
Registry last updated
Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.