Cancer of the Uterine Cervix
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECobas HPV DNA Test
Women will receive a home-sent sample for HPV self-testing
OTHERPapanicolau test
Women will be invited to come in for a physician-performed Pap test
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* No previous cervical cancer screening test in the last three years
Exclusion criteria
* pregnancy * previous hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. | 1 year | Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 336 |
| 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 | 331 |
| Total | 667 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 24 |
Baseline characteristics
| Characteristic | Papanicolau Test | Total | Cobas HPV DNA Test |
|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 10.8 | 42.2 years STANDARD_DEVIATION 10.9 | 42.3 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 106 Participants | 211 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants | 456 Participants | 231 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Relationship Status Single | 177 Participants | 352 Participants | 175 Participants |
| Relationship Status With a partner | 154 Participants | 315 Participants | 161 Participants |
| Sex: Female, Male Female | 331 Participants | 667 Participants | 336 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobas HPV DNA Test | 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 | 317 Participants |
| Papanicolau Test | 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 | 307 Participants |
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobas HPV DNA Test | Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. | 317 Participants |
| Papanicolau Test | Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. | 307 Participants |