Overview

This trial is active, not recruiting.

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
Treatments cervical papanicolaou test, cytology specimen collection procedure, questionnaire administration, screening method
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date March 2012
End date May 2018
Trial size 2000 participants
Trial identifier NCT01550783, 7489, NCI-2013-00745, P30CA015704, R01CA157469

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
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.
cytology specimen collection procedure Cytologic Sampling
Undergo home-based HPV screening
questionnaire administration
Ancillary studies
screening method
Undergo home-based HPV screening
(Experimental)
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.
cervical papanicolaou test Cervical Pap Test
Undergo standard of care Pap test screening
questionnaire administration
Ancillary studies
screening method
Undergo standard of care Pap test screening

Primary Outcomes

Measure
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
time frame: Up to 4 years
Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
time frame: Up to 4 years
Sensitivity and specificity for CIN 1+ of novel home-based testing
time frame: Up to 4 years
Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old
time frame: Up to 4 years
Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old
time frame: Up to 4 years

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
Principal investigator Nancy Kiviat
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Washington.
Location data was received from the National Cancer Institute and was last updated in August 2016.