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

Cervical Cancer Clinical Trial

Official title:

Hospital-based Epidemiological Study on the Distribution of Human Papillomavirus (HPV) Types in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) in New Zealand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328028
• Other study ID #: 111050
• Status: Completed
• Phase: N/A
• First received: March 31, 2011
• Last updated: August 23, 2012
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Testing of archived cervical cancer tissue samples
Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.
• Data collection
Log sheet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No