Atypical Squamous Cell of Undetermined SignificanceNCT01550783
Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
A study testing Cervical Papanicolaou Test, Cytology Specimen Collection Procedure and Questionnaire Administration in people with Atypical Squamous Cell of Undetermined Significance and Cervical Carcinoma, run by University of Washington at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atypical Squamous Cell of Undetermined Significance, Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3
- What is being tested?
- Cervical Papanicolaou Test, Cytology Specimen Collection Procedure and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,335 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to 16 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent in English
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Being tested
- Cervical Papanicolaou Test, Cytology Specimen Collection Procedure, Questionnaire Administration, Screening Method
- Keywords
- Cervical cancer, Atypical squamous cells of undetermined significance, Stage 0 cervical cancer, Cervical intraepithelial neoplasia grade 1, Cervical, intraepithelial neoplasia grade 2, Cervical intraepithelial neoplasia grade 3, Human papillomavirus, HPV
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, Uterine Cervical Dysplasia, Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Papanicolaou TestOther
Also called Cervical Pap Test
Undergo standard of care Pap test screening
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo home-based HPV screening
Questionnaire AdministrationOther
Ancillary studies
Screening MethodProcedure or surgery
Undergo standard of care Pap test screening
Screening MethodProcedure or surgery
Undergo home-based HPV screening
| Study group | Role | What they receive |
|---|---|---|
| Group I (home-based HPV screening) | 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Questionnaire Administration; Procedure: Screening Method |
| Group II (clinic-based standard of care 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. Receives: Other: Cervical Papanicolaou Test; Other: Questionnaire Administration; Procedure: Screening Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
Measured: Up to 4 years
Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atypical Squamous Cell of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,335 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nancy Kiviat, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550783
- Sponsor's protocol ID
- 7489
- Other IDs
- NCI-2013-00745, 7489, R01CA157469
- Status last verified
- Apr 2018
- First submitted
- 17 Feb 2012
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feder MA, Kulasingam SL, Kiviat NB, Mao C, Nelson EJ, Winer RL, Whitham HK, Lin J, Hawes SE. Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women. J Womens Health (Larchmt). 2019 Oct;28(10):1428-1435. doi: 10.1089/jwh.2018.7340. Epub 2019 Jul 2.
PubMed 31264912Mao C, Kulasingam SL, Whitham HK, Hawes SE, Lin J, Kiviat NB. Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. J Womens Health (Larchmt). 2017 Jun;26(6):609-615. doi: 10.1089/jwh.2016.5965. Epub 2017 Mar 23.
PubMed 28332888
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
- ClinicalTrials.gov ID
- NCT01550783
- Acronym / sponsor ID
- 7489
- 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
- Keywords
- Cervical cancer, Atypical squamous cells of undetermined significance, Stage 0 cervical cancer, Cervical intraepithelial neoplasia grade 1, Cervical, intraepithelial neoplasia grade 2, Cervical intraepithelial neoplasia grade 3, Human papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,335 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (home-based HPV screening) | Experimental | Other: Cytology Specimen Collection Procedure, Other: Questionnaire Administration, Procedure: Screening MethodParticipants 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 MethodParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to provide informed consent in English
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Papanicolaou TestAlso: Cervical Pap TestUndergo standard of care Pap test screening | Other | Group II (clinic-based standard of care screening) |
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo home-based HPV screening | Other | Group I (home-based HPV screening) |
| Questionnaire AdministrationAncillary studies | Other | Group I (home-based HPV screening), Group II (clinic-based standard of care screening) |
| Screening MethodUndergo standard of care Pap test screening | Procedure or surgery | Group II (clinic-based standard of care screening) |
| Screening MethodUndergo home-based HPV screening | Procedure or surgery | Group I (home-based HPV screening) |
Primary outcome
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
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.
Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
Time frame: Up to 4 years
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.
Sensitivity and specificity for CIN 1+ of novel home-based testing
Time frame: Up to 4 years
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.
Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old
Time frame: Up to 4 years
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
Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old
Time frame: Up to 4 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Derived from this study: PubMed 31264912Feder MA, Kulasingam SL, Kiviat NB, Mao C, Nelson EJ, Winer RL, Whitham HK, Lin J, Hawes SE. Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women. J Womens Health (Larchmt). 2019 Oct;28(10):1428-1435. doi: 10.1089/jwh.2018.7340. Epub 2019 Jul 2.
- Derived from this study: PubMed 28332888Mao C, Kulasingam SL, Whitham HK, Hawes SE, Lin J, Kiviat NB. Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. J Womens Health (Larchmt). 2017 Jun;26(6):609-615. doi: 10.1089/jwh.2016.5965. Epub 2017 Mar 23.
Related trials for Atypical Squamous Cell of Undetermined Significance
RecruitingPhase 2
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion
Recruiting
Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer
I) Atypical Squamous Cells of Undetermined Significance (ASC-US), II) Atypical Glandular Cells of Uncertain Significance (AGUS)
Active, not recruitingObservational study
Primary Cervical Cancer Screening by Self-sampling HPV Test
Human Papillomavirus Infection, Cervical Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Kiviat principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Papanicolaou Test, Cytology Specimen Collection Procedure and Questionnaire Administration in people with Atypical Squamous Cell of Undetermined Significance and Cervical Carcinoma, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old (time frame: Up to 4 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.