Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

Human Papillomavirus Infection Clinical Trial

Official title:

Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550783
• Other study ID #: 7489
• Secondary ID: NCI-2013-0074574
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: November 16, 2017

Study information

• Verified date: April 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1335
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Squamous Cell of Undetermined Significance
• Carcinoma in Situ
• Cervical Carcinoma
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3
• Health Status Unknown
• Human Papillomavirus Infection
• Low Grade Cervical Squamous Intraepithelial Neoplasia
• Neoplasms
• Papillomavirus Infections
• Squamous Intraepithelial Lesions of the Cervix
• Stage 0 Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Cervical Papanicolaou Test
Undergo standard of care Pap test screening
• Cytology Specimen Collection Procedure
Undergo home-based HPV screening
• Questionnaire Administration
Ancillary studies

Procedure:
• Screening Method
Undergo standard of care Pap test screening
• Screening Method
Undergo home-based HPV screening

Locations

Country	Name	City	State
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old		Up to 4 years
Primary	Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old		Up to 4 years
Primary	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.	Up to 4 years
Primary	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.	Up to 4 years
Primary	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.	Up to 4 years
Primary	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	Up to 4 years
Primary	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	Up to 4 years