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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01328028
First received: March 31, 2011
Last updated: August 23, 2012
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Cervical Cancer
 Other: Testing of archived cervical cancer tissue samples
Other: Data collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cervical specimen


Enrollment: 244
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328028

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01328028     History of Changes
Other Study ID Numbers: 111050
Study First Received: March 31, 2011
Last Updated: August 23, 2012
Health Authority: New Zealand: Medsafe

Keywords provided by GlaxoSmithKline:
Invasive cervical cancer
Human papillomavirus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013