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The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.
The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV-based screening | Experimental | Women 23-29 invited to cervical screening will have their samples analyzed for HPV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV testing | Diagnostic Test | All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 1. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 2. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 3. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 4. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 5. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 6. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 1. |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with a cervix and with a personal ID number indicating that they are a female, are eligible.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joakim Dillner, MD, PhD | Contact | +46 (0) 72-468 24 60 | joakim.dillner@ki.se | |
| Miriam Elfström, PhD | Contact | +46 (0) 70-381 62 77 | miriam.elfstrom@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Joakim Dillner, MD, PhD | Karolinska University Hospital/Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region of Skåne | Active, not recruiting | Lund | Skåne County | 221 00 | Sweden | |
| Region Stockholm |
IPD has been discussed but a plan isn't finalized.
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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|
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 8. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 9. |
| Incidence of cervical cancer | Cervical cancer incidence in the intervention group compared to a historical control group. | Measured once during 1 year, year 10. |
| Cost-effectiveness of the new screening method |
Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. |
| Measured once during 1 year, year 2. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 3. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 4. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 5. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 6. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 7. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 8. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 9. |
| Cost-effectiveness of the new screening method | Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data. | Measured once during 1 year, year 10. |
| Recruiting |
| Stockholm |
| 102 39 |
| Sweden |
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |