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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

This study has been completed.
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01480219
First received: November 23, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Non-Melanoma Skin Carcinoma
 Drug: voriconazole (Vfend)
Other: no voriconazole (Vfend)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 467
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Any Voriconazole 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 Name: Vfend
No Voriconazole 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.
Other Name: Vfend

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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. 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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480219

Sponsors and Collaborators
Pfizer
University of Southern California
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01480219     History of Changes
Other Study ID Numbers: A1501098
Study First Received: November 23, 2011
Results First Received: February 4, 2013
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
voriconazole
non-melanoma skin cancer
confounding
statistical adjustment
 risk adjustment
lung transplant
heart/lung transplant
immunosuppression

Additional relevant MeSH terms:
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
 Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013