Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
| Sponsors |
Lead Sponsor: University of Washington Collaborator: National Cancer Institute (NCI) |
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| Source | University of Washington | ||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Overall Status | Completed | ||||||||||||||||
| Start Date | March 2012 | ||||||||||||||||
| Completion Date | November 16, 2017 | ||||||||||||||||
| Primary Completion Date | November 16, 2017 | ||||||||||||||||
| Phase | N/A | ||||||||||||||||
| Study Type | Interventional | ||||||||||||||||
| Primary Outcome |
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| Enrollment | 1335 | ||||||||||||||||
| Condition | |||||||||||||||||
| Intervention |
Intervention Type: Other Intervention Name: Cervical Papanicolaou Test Description: Undergo standard of care Pap test screening Arm Group Label: Group II (clinic-based standard of care screening) Other Name: Cervical Pap Test Intervention Type: Other Intervention Name: Cytology Specimen Collection Procedure Description: Undergo home-based HPV screening Arm Group Label: Group I (home-based HPV screening) Other Name: Cytologic Sampling Intervention Type: Other Intervention Name: Questionnaire Administration Description: Ancillary studies Intervention Type: Procedure Intervention Name: Screening Method Description: Undergo standard of care Pap test screening Arm Group Label: Group II (clinic-based standard of care screening) Intervention Type: Procedure Intervention Name: Screening Method Description: Undergo home-based HPV screening Arm Group Label: Group I (home-based HPV screening) |
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| Eligibility |
Criteria:
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 Gender: Female Minimum Age: 21 Years Maximum Age: N/A Healthy Volunteers: Accepts Healthy Volunteers |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
April 2018 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||||||||||||
| Condition Browse | |||||||||||||||||
| Number Of Arms | 2 | ||||||||||||||||
| Arm Group |
Label: Group I (home-based HPV screening) Type: Experimental Description: 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. Label: Group II (clinic-based standard of care screening) Type: Experimental Description: 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. |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Screening Masking: None (Open Label) |
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