Human Papillomavirus Epidemiology in Nigeria

Summary

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.

Conditions

• Human Papillomavirus 18
• Cervical Intraepithelial Neoplasia
• Human Papillomavirus 16
• Uterine Cervical Neoplasms

Interventions

DEVICE

OncoE6

HPV oncoprotein assay

DEVICE

EVA System

low-cost colposcope

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mark H Schiffman, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-06

Primary Completion

2019-12-30

Completion

2020-11-10

Countries

• Nigeria

Study Locations