Human Papillomavirus Epidemiology in Nigeria

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00804466
First received: December 5, 2008
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

Background:

  • Cervical cancer is caused by persistent infection of the lining of the cervix with some kinds of human papillomaviruses (HPV). These HPV infections are distantly related to the viruses that cause warts on the skin. Like common wart viruses, most women who have cervical infections with HPV resolve the infections within 2 years without any need for treatment. Cervical infections that do not go away may cause disease that can turn into cancer after many years.
  • Only one study has been done in Nigeria to learn how many women have HPV infection. The results of the study differed from most other studies in the world because older women were much more likely to be infected. This study with learn whether the results found in the previous study are true in Irun also, the site of the current study.

Objectives:

  • To examine the age distribution of HPV infection and relationship to cancer of the cervix among Nigerian women.
  • To understand how different screening methods, including HPV testing, could best reduce the risk of cervical cancer in Nigerian women.

Eligibility:

- Women residing in Irun, Nigeria, who are 15 years of age or older.

Design:

  • Participants complete a brief questionnaire related to demographics, household and living conditions and a longer survey with questions related to reproductive history, family history, illnesses, stressful life events and sexual history (U. of Michigan collaboration).
  • Participants have a cervical examination, HPV test, Pap test and blood test.
  • Women whose tests show they are infected with HPV or have cervical disease will do the following:
  • see a doctor and have cervical biopsies of all white abnormal areas (removal of a small tissue sample from the cervix)
  • have photographs of the cervix taken
  • have a cervical scraping for a new kind of HPV test.
  • Some women with normal test results are also asked to see a doctor to check the validity of the testing
  • Women with cervical disease receive treatment by a specialist and remain in the program until treatment is successfully completed or a final diagnosis is reached.
  • Participants may be contacted for followup up to 5 years after the final diagnosis is made.

Condition
Cervical Cancer
Cervical Intraepithelial Neoplasia
Human Papillomavirus Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiologic and Molecular Features of Cervical Cancer in Nigeria - Project Itoju (Care)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1500
Study Start Date: December 2008
Detailed Description:

BACKGROUND: Cervical cancer, caused by persistent infection with approximately 15-20 genotypes of carcinogenic human papillomavirus (HPV) infection, is the second leading cause of female cancer. Cytology (Pap smears) and the new HPV vaccines are not widely available in poor regions. Immediate treatment of HPV-infected older women by cryotherapy might have greater impact.

Although the same HPV types cause cervical cancer everywhere, and the same stages (infection, persistence vs. clearance, progression to precancer, and invasion) typify cervical carcinogenesis, the patterns of age-specific prevalence of HPV vary widely. These patterns are important for secondary prevention strategies relying on HPV DNA testing.

In many regions, including the US, HPV infections appear as classical sexually-transmitted agents, with peak cervical DNA prevalence at young ages (approximately 20) and low prevalence at older ages. However, in Nigeria, HPV prevalence is high (greater than or equal to 15%) at all ages according to the one study performed in urban Ibadan by Franceschi s group at IARC (n=932 women). This pattern is very uncommon. High prevalence at all ages would preclude use of HPV testing in low-cost strategies, due to poor positive predictive value. One possibly relevant element is the marital structure in Nigeria; a man often has multiple wives.

OBJECTIVES: The major objectives are: 1) To estimate age-specific HPV prevalences in Irun, Nigeria; 2) To investigate epidemiologic risk factors for HPV and cervical intraepithelial neoplasia in this population; 3) To examine the performance of screening options; 4) To assess the correlation of HPV among co-wives, comparing households with multiple wives with those with single wives; and 5) To validate the performance of rapid HPV, an inexpensive HPV test designed for public-sector use in settings like Irun.

ELIGIBILITY: All non-pregnant women aged 15+, without hysterectomy, will be eligible if they can provide written informed consent. Unmarried women less than 21 will be enrolled only with parental consent. Sexually active women will be examined and asked for cervical specimens; self-reported virginal women will be asked for a 10-ml blood sample only.

DESIGN: This is a cross-sectional screening study of 1500 women in Irun, a Nigerian village. Unlike the IARC study, we will incorporate cytology, visual inspection, and colposcopic biopsy of women that test positive by any of the three screening tests. We will determine whether HPV infection at various ages is related to risk of cervical abnormalities. The analyses will include descriptive trend data, multivariable modeling of HPV determinants, and clinical epidemiologic analysis of relative screening test performance in detecting cervical neoplasia.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Females who are 15 years to 99 years of age

EXCLUSION CRITERIA:

  • Previous hysterectomy
  • Current pregnancy
  • Inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804466

Locations
Nigeria
Irun Local Government Clinic
Irun, Nigeria
Obafemi Awolowo University Teaching Hospital
Ole-Ife, Nigeria
Sponsors and Collaborators
Investigators
Principal Investigator: Mark H Schiffman, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00804466     History of Changes
Other Study ID Numbers: 999909045, 09-C-N045
Study First Received: December 5, 2008
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cervix
HPV
Cancer
CIN
Epidemiology
Screening

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Warts
Carcinoma in Situ
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014