Human Papillomavirus Epidemiology in Nigeria

NCT00804466 | Completed

• 2 other identifiers: 99990904509-C-N045
• Study Type: interventional
• Target: 1,466
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Human Papillomavirus; Cervical Cancer; Screening

Outcome Measures

Primary Outcomes (1)

• Sensitivity of triage methods

  Cervical Histopathology

  cross-sectional

Study Arms (1)

Women referred to colposcopy clinic

EXPERIMENTAL

Triage tests for diagnosis of cervical pre-cancer amongHPV positive women

Device: OncoE6; Device: EVA System

Interventions

OncoE6 DEVICE

HPV oncoprotein assay

Women referred to colposcopy clinic

EVA System DEVICE

low-cost colposcope

Women referred to colposcopy clinic

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females who are 15 years to 99 years of age

You may not qualify if:

• Previous hysterectomy
• Current pregnancy
• Inability to give informed consent

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Obafemi Awolowo University Teaching Hospital

Ile-Ife, Nigeria

Location

Related Publications (3)

• Clarke MA, Gage JC, Ajenifuja KO, Wentzensen NA, Adepiti AC, Wacholder S, Burk RD, Schiffman M. A population-based cross-sectional study of age-specific risk factors for high risk human papillomavirus prevalence in rural Nigeria. Infect Agent Cancer. 2011 Jul 29;6:12. doi: 10.1186/1750-9378-6-12.

  PMID: 21801395 BACKGROUND

• Gage JC, Ajenifuja KO, Wentzensen NA, Adepiti AC, Eklund C, Reilly M, Hutchinson M, Wacholder S, Harford J, Soliman AS, Burk RD, Schiffman M. The age-specific prevalence of human papillomavirus and risk of cytologic abnormalities in rural Nigeria: implications for screen-and-treat strategies. Int J Cancer. 2012 May 1;130(9):2111-7. doi: 10.1002/ijc.26211. Epub 2011 Aug 5.

  PMID: 21630264 BACKGROUND

• Gage JC, Ajenifuja KO, Wentzensen N, Adepiti AC, Stoler M, Eder PS, Bell L, Shrestha N, Eklund C, Reilly M, Hutchinson M, Wacholder S, Castle PE, Burk RD, Schiffman M. Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria. Int J Cancer. 2012 Dec 15;131(12):2903-9. doi: 10.1002/ijc.27563. Epub 2012 Apr 27.

  PMID: 22473652 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Mark H Schiffman, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: July 6, 2009
• Primary Completion: December 30, 2019
• Study Completion: November 10, 2020
• Last Updated: November 25, 2020

Record last verified: 2019-11

Locations

NG (1)