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

Completed

• Conditions: Cervical Cancer
• Interventions: Other: Testing of archived cervical cancer tissue samples; Other: Data collection

• Registration Number: NCT01328028
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-03-31
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Posted: 2011-04-04
• Status Verified: 2011-06
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 244

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Data collection	Subjects diagnosed with invasive cervical cancer
Group A	Testing of archived cervical cancer tissue samples	Subjects diagnosed with invasive cervical cancer

Primary Outcome Measures

Name	Time	Method
Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer	At least the last 3 years from the time of study start

Secondary Outcome Measures

Name	Time	Method
Occurrence of HPV-16/ HPV-18 co-infection with other high-risk HPV types in women with invasive cervical cancer	At least the last 3 years from the time of study start
Occurrence of low-risk HPV types in women diagnosed with invasive cervical cancer	At least the last 3 years from the time of study start
Occurrence of other high-risk HPV types in women with invasive cervical cancer	At least the last 3 years from the time of study start