An interventional study of Cervical Papanicolaou Test and Cytology Specimen Collection Procedure in Atypical Squamous Cell of Undetermined Significance, Cervical Carcinoma and Cervical Intraepithelial Neoplasia Grade 2/3, sponsored by University of Washington. Completed at 2 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by University of Washington · Not applicable, Interventional, and Screening
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:
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 1,335 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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.
Other: Cytology Specimen Collection Procedure · 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.
Other: Cervical Papanicolaou Test · Other: Questionnaire Administration · Procedure: Screening Method
Undergo standard of care Pap test screening
Also known as: Cervical Pap Test
Undergo home-based HPV screening
Also known as: Cytologic Sampling
Ancillary studies
Undergo standard of care Pap test screening
Undergo home-based HPV screening
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
Time frame: Up to 4 years
Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old
Time frame: Up to 4 years
Overall cost-effectiveness and acceptability
The results from the trial (sensitivity, specificity, and costs) will be used in conjunction with a Markov model to determine cost per LY and cost per QALY. Model outcomes (per 100,000 screened) will include the expected numbers of false-positive test results, colposcopies, cases of CIN 1+, cases of cancer, cancer deaths, life expectancy and quality adjusted life-expectancy. Strategies will be compared using incremental cost-effectiveness ratios. Costs and outcomes will be discounted at 3% annually. One, 2-way and probabilistic sensitivity analyses conducted for all inputs to the models.
Time frame: Up to 4 years
Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
Time frame: Up to 4 years
Sensitivity and specificity for CIN 1+ of novel home-based testing
An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
Time frame: Up to 4 years
Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old
Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty
Time frame: Up to 4 years
Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old
Estimates of sensitivity and specificity for detection of CIN 1 will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty
Time frame: Up to 4 years
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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