Non-Melanoma Skin CarcinomaNCT01480219

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

An observational study of Non-Melanoma Skin Carcinoma, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Melanoma Skin Carcinoma
What is being tested?: voriconazole (Vfend) and no voriconazole (Vfend)
How many people: 467 participants
Where: No sites listed yet
Study dates: Aug 2011to Mar 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Non-Melanoma Skin Carcinoma
Being tested: voriconazole (Vfend), no voriconazole (Vfend)
Keywords: voriconazole, non-melanoma skin cancer, confounding, statistical adjustment, risk adjustment, lung transplant, heart/lung transplant, immunosuppression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01480219
Study group	Role	What they receive
Any Voriconazole		Not described Receives: Drug: voriconazole (Vfend)
No Voriconazole		Not described Receives: Other: no voriconazole (Vfend)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Mar 2012

First posted28 Nov 2011 (estimated)
Study startAug 2011
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Melanoma Skin CarcinomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01480219
Sponsor's protocol ID: A1501098
Status last verified: Feb 2013
First submitted: 23 Nov 2011
Last updated: 11 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Harvesting Cells for Experimental Cancer Treatments
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Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
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RecruitingObservational study
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All Non-Melanoma Skin Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01480219
Acronym / sponsor ID: A1501098
Conditions: Non-Melanoma Skin Carcinoma
Keywords: voriconazole, non-melanoma skin cancer, confounding, statistical adjustment, risk adjustment, lung transplant, heart/lung transplant, immunosuppression
Study type: Observational
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: University of Southern California
Study start: Aug 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 28 Nov 2011 (estimated)
Results: Posted 11 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Any Voriconazole	–	Drug: voriconazole (Vfend)
No Voriconazole	–	Other: no voriconazole (Vfend)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
voriconazole (Vfend)Also: VfendVoriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.	Drug	Any Voriconazole
no voriconazole (Vfend)Also: VfendVoriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.	Other	No Voriconazole

Primary outcome

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

Results and safety

Results posted to the registry on 11 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Voriconazole	325	325
Voriconazole	142	142

Primary outcome: 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. Number. Unit: participants

Measure	No Voriconazole n = 325	Voriconazole n = 142
Value	34	23

No Voriconazole vs Voriconazole: Hazard Ratio (HR): 1.74 (95% CI 1.02 to 2.96), p = 0.042, Regression, Cox
No Voriconazole vs Voriconazole: Hazard Ratio (HR): 1.23 (95% CI 0.71 to 2.14), p = 0.453, Regression, Cox

Population analysed: Final analysis set included participants who met the eligibility criteria.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Voriconazole	0 of 0	0 of 0	Not reported
Voriconazole	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Non-Melanoma Skin Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Harvesting Cells for Experimental Cancer Treatments
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Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
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RecruitingObservational study
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RecruitingPhase 1
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Non Small Cell Lung Cancer, Triple Negative Breast Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Melanoma Skin Carcinoma, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01480219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2013.