Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta

NCT00443313 | Completed

• 2 other identifiers: 99990708007-C-N080
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular Pap tests (also called Pap smears), which check for changes in the cells of the cervix. Because many women in the United States have regular Pap smears, cervical cancer is not common in this country. However, the disease is common among women in the Mississippi Delta because of poor participation in screening programs.
• The major causes of cervical cancer are persistent human papillomaviruses (HPV) infection by cancer-associated HPV types and lack of screening. These viruses cause an infection that often goes away by itself, but if it does not go away, over a long time lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap smears and then treated. Objectives:
• To determine whether an at-home self-collection method for obtaining cells from the cervix can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t go to the health clinic regularly. Eligibility:
• Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie, Mississippi.
• Women between 26 and 65 years of age who are not pregnant and who have not had a hysterectomy. Design: Screening study participants undergo the following:
• The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.
• Pelvic examination and Pap test. For this test, the woman lies on an exam table and the doctor inserts an instrument called a speculum into the vagina, opening it to see the cervix. A special brush is used to take a few cells from the cervix. The cells are placed on a glass slide and sent to a lab for examination.
• Cervical cell specimen collection using an at-home self-collection kit that participants will use at home after 2 weeks
• At-home self-collection by participant after 2 weeks.
• Referral to a doctor for follow-up care, if needed.
• Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV and for some women with a normal smear. Colposcopy study participants undergo the following:
• The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.
• Colposcopy, an exam in which the doctor examines the cervix using a light and looks through a magnifying device to see if there is any abnormal tissue on the cervix. During this exam, the doctor may remove a small sample of tissue to diagnose any abnormality. Participants also have a sample collected using the self-collection kit.
• At-home cervical sample collection by participant after 2 weeks.
• Notification if further medical care is required and treatment if the biopsy looks abnormal.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical neoplasia; Screening; HPV; Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Detection CIN II+

  During course of study

Eligibility Criteria

• Age: 26 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited.

You may not qualify if:

• Women under 26 or over 65 years of age.
• Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect.
• Women who have had a total hysterectomy.
• Women who have an overt cancerous lesion visible upon exam by the clinician.
• Other reasons to exclude women include the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, Roteli-Martins CM, Teixeira J, Blatter MM, Korn AP, Quint W, Dubin G; GlaxoSmithKline HPV Vaccine Study Group. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet. 2004 Nov 13-19;364(9447):1757-65. doi: 10.1016/S0140-6736(04)17398-4.

  PMID: 15541448 BACKGROUND

• Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.

  PMID: 16514137 BACKGROUND

• Wang SS, Sherman ME, Hildesheim A, Lacey JV Jr, Devesa S. Cervical adenocarcinoma and squamous cell carcinoma incidence trends among white women and black women in the United States for 1976-2000. Cancer. 2004 Mar 1;100(5):1035-44. doi: 10.1002/cncr.20064.

  PMID: 14983500 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia

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

Study Officials

• Julia C Gage, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: January 24, 2007
• Study Completion: June 25, 2015
• Last Updated: April 5, 2018

Record last verified: 2015-06-25

Locations

US (1)