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The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.
Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cobas HPV DNA test | Experimental | Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. |
|
| Papanicolau test | Active Comparator | Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cobas HPV DNA Test | Device | Women will receive a home-sent sample for HPV self-testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing | Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. | Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Data will be used for scientific publications.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cobas HPV DNA Test | Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. |
| FG001 | Papanicolau Test | Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician. Papanicolau test: Women will be invited to come in for a physician-performed Pap test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cobas HPV DNA Test | Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing |
| BG001 | Papanicolau Test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing | Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing. | Posted | Count of Participants | Participants | 1 year |
|
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Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cobas HPV DNA Test | Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Manuela Viviano | Geneva University Hospitals | 07955 32 272 | manuela.viviano@hcuge.ch |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Papanicolau test | Other | Women will be invited to come in for a physician-performed Pap test |
|
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Relationship Status | Count of Participants | Participants | No |
|
|
|
| Secondary | Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. | Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Papanicolau Test | Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician. Papanicolau test: Women will be invited to come in for a physician-performed Pap test. N=331 | 0 | 0 | 0 | 0 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |