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OpenTrials
Completed

NCT Number: NCT01207999

Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer

The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.

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Key information

Conditions

Infections, Papillomavirus Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Accra, Ghana

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.
  • Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.
  • Written or oral-witnessed informed consent obtained from the subject prior to any study procedure.
  • No prior chemo- or radiotherapy for cervical cancer.

Exclusion criteria

Not applicable

Treatment and study plan

Collection of cervical cancer tissue samples

Procedure

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

Data Collection

Other

Questionnaire completion

Primary outcomes

  1. Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer

    Time frame: Average time frame: 6-12 months

  2. Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma

    Time frame: Average time frame: 6-12 months

Secondary outcomes

  1. Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer

    Time frame: Average time frame:6-12 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • African Organization for Research and Training in Cancer (AORTIC)
  • University of Cape Town

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2010
Registry last updated
Nov 22, 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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