Human Papillomavirus (HPV) Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer in New Zealand

NCT ID: NCT01328028

Last Updated: 2012-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-04-30

Brief Summary

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The aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.

Detailed Description

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Conditions

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Cervical Cancer

Keywords

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Invasive cervical cancer Human papillomavirus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Subjects diagnosed with invasive cervical cancer

Testing of archived cervical cancer tissue samples

Intervention Type OTHER

Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.

Data collection

Intervention Type OTHER

Log sheet

Interventions

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Testing of archived cervical cancer tissue samples

Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.

Intervention Type OTHER

Data collection

Log sheet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A female aged 18 years and above at the time of cervical specimen collection, and currently residing in New Zealand.
* Histological diagnoses of invasive cervical cancer stage IB or greater, within at least the last 3 years.
* Written informed consent obtained from the subject/ next of kin/ Legally acceptable representative.
* Availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy.
* The cervical specimen should be of appropriate size and with regular tissue specimens.
* The cervical specimen should be adequately preserved.
* All links to the subject's identity should be removed from the paraffin block.

Exclusion Criteria

Not Applicable.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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New Zealand

References

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Sykes P, Gopala K, Tan AL, Kenwright D, Petrich S, Molijn A, Chen J. Type distribution of human papillomavirus among adult women diagnosed with invasive cervical cancer (stage 1b or higher) in New Zealand. BMC Infect Dis. 2014 Jul 8;14:374. doi: 10.1186/1471-2334-14-374.

Reference Type DERIVED
PMID: 25000939 (View on PubMed)

Other Identifiers

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111050

Identifier Type: -

Identifier Source: org_study_id