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

This study has been completed.
Sponsor:
Collaborators:
University of Cape Town
African Organization for Research and Training in Cancer (AORTIC)
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01207999
First received: September 22, 2010
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Infections, Papillomavirus
Cervical Cancer
 Procedure: Collection of cervical cancer tissue samples
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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

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

Biospecimen Retention:   Samples With DNA

Cervical specimen


Enrollment: 591
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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:

Not applicable

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01207999     History of Changes
Other Study ID Numbers: 109117
Study First Received: September 22, 2010
Last Updated: November 21, 2012
Health Authority: Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)
South Africa: Medicines Control Council

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

ClinicalTrials.gov processed this record on May 23, 2013