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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      Background: Cytology screening programs have effectively reduced cervical cancer incidence
      and mortality in the U.S. by greater than 75%. However, these programs requiring repeated
      clinician-administered Pap smears do not adequately cover medically-underserved populations.
      Based partly on HREB/DCEG etiologic research, we now know that carcinogenic types of human
      papillomavirus (HPV) cause virtually all cases of cervical cancer. Supported by our
      translational work with DCP, HPV DNA testing is already approved by the FDA as an adjunctive
      screening modality to cytology in this country and as a primary screening modality to
      cytology in this country and as a primary screening modality internationally. A validated
      screening program of HPV DNA testing of self-collected cervicovaginal specimens would permit
      wider coverage screening than cytology in the populations underserved by cytology-based
      testing like the Mississippi Delta region.

      Objective: To assess the technical feasibility (i.e. non-inferiority or equivalence to
      cytology for detection of cervical precancer and cancer) of cervical cancer screening based
      on self-collection and HPV DNA testing of cervicovaginal specimens from women aged greater
      than or equal to 30 years old who live in the Mississippi Delta.

      Methods: One thousand women will be enrolled during 18 months, including 500 attending
      colposcopy due to cytologic abnormality, 250 women who regularly attend a screening clinic,
      and 250 unscreened women who have not had a Pap smear within the last 3 years (according to
      current screening guidelines) but recruited to attend a screening. Three clinical specimens
      will be collected from each woman. A cervicovaginal specimen (for HPV testing) and a cervical
      specimen (for cytology and HPV testing) will be collected from each woman by the physician.
      At the time of the clinic visit women will be give a kit for self-collection of a second
      cervicovaginal specimen (for HPV testing) to be returned by mail within two weeks. All three
      specimens from each woman will be tested by two clinical DNA tests that use pooled-probes for
      detection of carcinogenic HPV: an FDA-approved signal amplification test (Hybrid Capture 2
      from Digene) and a new DNA amplification test (AMPLICOR from Roche) currently in clinical
      trials. Specimens will also be tested retrospectively by a research PCR asay that detects 37
      HPV types, which will help us evaluate the performance of the two clinical HPV tests. Women
      attending their screening visit who test positive by cytology (atypical squamous cells of
      undetermined significance or worse) or for carcinogenic HPV will be referred to colposcopy
      along with a random sample of HPV negative, cytologic negative women (n equals 100).

      Analysis: We will compare the clinical performance of HPV DNA testing of self-collected
      specimens to that of cytology (at a threshold of atypical squamous cells of unknown
      significance (ASCUS) or more severe) for detection of histologically confirmed cervical
      intraepithelial neoplasia grade 2 (CIN2) or more severe (greater than or equal to CIN2).
      Cytology results will be based on standard-of-care cytology screening for women attending the
      screening visit and repeat cytology for women attending colposcopy. An estimated 150 cases of
      greater than or equal to CIN2 will be identified. This is an equivalence study, where we wish
      to reject the null hypothesis that HPV self-testing is greater than 10% less sensitive than
      cytology. Assuming cytology has a 75% sensitivity for greater than or equal to CIN2, a sample
      size of 150 subjects has 84% power (alpha=0.05) (one-sided non-inferiority or equivalence
      test of correlated proportions) to rule out a 10% decrement in sensitivity for
      self-collection with HPV DNA testing compared with cytology will guide whether the new
      technique could be broadly introduced for cervical cancer screening.
    


Study Type

Observational


Primary Outcome

Detection CIN II+


Condition

Cervical Intraepithelial Neoplasia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

664

Start Date

January 24, 2007

Completion Date

June 25, 2015


Eligibility Criteria

        -  INCLUSION CRITERIA:

        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.

        EXCLUSION CRITERIA:

        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.
      

Gender

Female

Ages

26 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Julia C Gage, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00443313

Organization ID

999907080

Secondary IDs

07-C-N080

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Julia C Gage, Ph.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

June 25, 2015