Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
| Registry | NCT01550783 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, screening |
| Enrollment | 1335 (Actual) |
| Sponsor | University of Washington (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Atypical Squamous Cell of Undetermined Significance, Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Health Status Unknown, Human Papillomavirus Infection, Low Grade Cervical Squamous Intraepithelial Neoplasia, Stage 0 Cervical Cancer |
| Interventions | Cervical Papanicolaou Test, Cytology Specimen Collection Procedure, Questionnaire Administration, Screening Method (Other, procedure) |
| Dates | start 2012-03-01, primary completion 2017-11-16, completion 2017-11-16, first posted 2012-03-12, last updated 2020-07-31 |
| Locations | 2 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Atypical Squamous Cell of Undetermined Significance All trials for Cervical Carcinoma All trials of Cervical Papanicolaou Test All trials of Cytology Specimen Collection Procedure
This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.
PRIMARY OBJECTIVES:
I. Compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) of two screening approaches:
* Novel approach: every 3 years high risk-human papillomavirus (HR-HPV) testing of (at home) self-collected samples with in-clinic cytology of HR-HPV positive women and referral to colposcopy of women with cytology > atypical squamous cells of uncertain significance (ASCUS); repeat HPV testing of HR-HPV positive but cytology negative women at one year;
* Currently recommended approach: for women < 30: every 3 years in-clinic cytology screening, with HPV based triage of women with ASCUS and referral to colposcopy of all women with squamous intraepithelial lesion (SIL) and/or HPV+ ASCUS; for women 30+, screening by Papanicolaou (Pap) and HPV, every 2-3 year (depending on previous history) with referral to colposcopy of those who are HPV 16/18+ or with cytology > ASCUS; retesting of those who are positive for other HR-HPV at one year.
II. Compare these two approaches with respect to overall cost-effectiveness and acceptability.
III. Determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women < 30.
OUTLINE: Participants are randomized to 1 of 2 arms.
GROUP I (home-based HPV screening): Participants collect 2 vaginal specimens using polyester swabs. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.
GROUP II (clinic-based standard of care screening): Participants undergo Pap testing. Participants with a positive Pap test undergo standard of care, including colposcopy, HPV testing, cervical biopsy and/or endocervical curettage (ECC). Participants with cervical biopsies showing precancerous changes requiring treatment may undergo loop electrosurgical excision procedure (LEEP) or are referred to appropriate care.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group I (home-based HPV screening) | Experimental | Other: Cytology Specimen Collection Procedure; Other: Questionnaire Administration; Procedure: Screening Method | Participants collect 2 vaginal specimens using polyester swabs that are then placed in a specimen tube. Specimens are then submitted to the Harborview Medical Center clinical pathology lab. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II. |
| Group II (clinic-based standard of care screening) | Experimental | Other: Cervical Papanicolaou Test; Other: Questionnaire Administration; Procedure: Screening Method | Participants undergo standard of care cervical cancer screening and follow-up. That is, participants undergo Pap testing. Participants with an abnormal Pap test undergo HPV testing, colposcopy, cervical biopsy and/or ECC. Participants with cervical biopsies showing precancerous changes are offered to undergo LEEP or are referred to appropriate care. |
Sex: Female, ages: 21 Years to any, accepts healthy volunteers
Inclusion Criteria: * Able to provide informed consent in English Exclusion Criteria: * Have had hysterectomy * Currently pregnant * Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years * Received colposcopy of cervix within TWO years * Received Pap test within ONE year * Immunocompromised (positive human immunodeficiency virus \[HIV\] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs) * Decisionally impaired adults requiring a legally authorized representative
| Facility | City | Country | Status |
|---|---|---|---|
| University of Minnesota/Masonic Cancer Center | Minneapolis, Minnesota | United States | |
| Fred Hutch/University of Washington Cancer Consortium | Seattle, Washington | United States |
NIH grants: R01CA157469