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Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 remove self sample kit at gp consulting room or perform pap smear : Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room. Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). |
|
| Group 2 | Experimental | Group 2 perform self sample at home or pap smear : Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 remove self sample kit at gp consulting room or perform pap smear | Behavioral | Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling. Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation / no participation to complete cervical cancer screening | Uncompleted cervical cancer screening is defined as one of the followings :
| 9 months after postal mail |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken HAGUENOER, MD-PHD | Centre de coordination des dépistages des cancers, Tours, France | Study Director |
| Somany SENGCHANH, MD-PHD | Centre de coordination des dépistages des cancers, Tours, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Tours | Tours | Indre Et Loire | 37000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35834620 | Result | Boyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13. |
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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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| ID | Term |
|---|---|
| D065006 | Papanicolaou Test |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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|
| Group 2 perform self sample at home or pap smear | Behavioral | Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory. |
|
| 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 |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |