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Completed

NCT Number: NCT01328028

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testing of archived cervical cancer tissue samples

Other

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

Data Collection

Other

Log sheet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 4, 2011
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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