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

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ClinicalTrials.gov Identifier: NCT01328028
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment
Cervical Cancer Other: Testing of archived cervical cancer tissue samples Other: Data collection

Study Design
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Study Type : Observational
Actual Enrollment : 244 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
Subjects diagnosed with invasive cervical cancer
 Other: Testing of archived cervical cancer tissue samples
Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.

Other: Data collection
Log sheet


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer [ Time Frame: At least the last 3 years from the time of study start ]

Secondary Outcome Measures :
  1. Occurrence of other high-risk HPV types in women with invasive cervical cancer [ Time Frame: At least the last 3 years from the time of study start ]
  2. Occurrence of HPV-16/ HPV-18 co-infection with other high-risk HPV types in women with invasive cervical cancer [ Time Frame: At least the last 3 years from the time of study start ]
  3. Occurrence of low-risk HPV types in women diagnosed with invasive cervical cancer [ Time Frame: At least the last 3 years from the time of study start ]

Biospecimen Retention:   Samples With DNA
Cervical specimen

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged >= 18 years at the time that the cervical specimen was taken, and diagnosed with invasive cervical cancer stage IB or greater
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328028


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01328028    
Other Study ID Numbers: 111050
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: June 2011
Keywords provided by GlaxoSmithKline:
Invasive cervical cancer
Human papillomavirus
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases