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

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ClinicalTrials.gov Identifier: NCT01207999
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : November 22, 2012
Sponsor:
Collaborators:
University of Cape Town
African Organization for Research and Training in Cancer (AORTIC)
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Infections, Papillomavirus Cervical Cancer Procedure: Collection of cervical cancer tissue samples Other: Data collection

Study Type : Observational
Actual Enrollment : 591 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer
Study Start Date : October 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
Group A
Subjects diagnosed with invasive cervical cancer
Procedure: Collection of cervical cancer tissue samples
Cervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing.

Other: Data collection
Questionnaire completion




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Cervical specimen


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women aged ≥ 21 years at the time the cervical specimen is taken, diagnosed with cervical lesion macroscopically suggestive of invasive cervical cancer, scheduled for cervical biopsy as per routine procedure.
Criteria

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:


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): NCT01207999


Locations
Ghana
GSK Investigational Site
Accra, Ghana
GSK Investigational Site
Kumasi, Ghana
Nigeria
GSK Investigational Site
Ibadan, Nigeria
GSK Investigational Site
Lagos, Nigeria
South Africa
GSK Investigational Site
Observatory, Western Province, South Africa, 7935
Sponsors and Collaborators
GlaxoSmithKline
University of Cape Town
African Organization for Research and Training in Cancer (AORTIC)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01207999     History of Changes
Other Study ID Numbers: 109117
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Keywords provided by GlaxoSmithKline:
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