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

NCT01480219 | Completed Results

• 1 other identifier: A1501098
• Study Type: observational
• Target: 467
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-Melanoma Skin Carcinoma

Keywords

voriconazole; non-melanoma skin cancer; confounding; statistical adjustment; risk adjustment; lung transplant; heart/lung transplant; immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Any Voriconazole

Drug: voriconazole (Vfend)

No Voriconazole

Other: no voriconazole (Vfend)

Interventions

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.

Also known as: Vfend

Any Voriconazole

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.

Also known as: Vfend

No Voriconazole

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• University of Southern California: collaborator

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 11, 2013
• Results First Posted: March 11, 2013

Record last verified: 2013-02