Clinical trial · Interventional
Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner
Participation in Screening for Cervical Cancer: Interest of a Human Papillomavirus (HPV) Self-sampling Device Provided by the General Practitioner; a Cluster Randomized Clinical Trial
NCT02749110CI-TRIAL-00102527PaCUDAHL-GécompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Malignant Tumor of Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaginal self-sampling brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-sampling for HPV test
- description
- Invitation to participate to the screening process by means of the usual care (pap-test) or the provision of a vaginal self-sampling brush (Evalyn Brush°). Self-collected samples are mailed to a central lab for HPV testing.
- interventionNames
- Device: Vaginal self-sampling brush
- type
- NO_INTERVENTION
- label
- Usual care (Pap test)
- description
- Intervention: invitation to participate to the screening process by means of the usual care (pap-test).
Primary outcomes (1)
- measure
- Rate of women terminating the whole diagnostic process.
- timeFrame
- For screening: 12 months; for follow-up of screened positive subjets: 18 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * To be a woman * Aged from 30 to 65 years (30 and 65 years included) * Without reimbursement of a pap-test by the health insurance for more than 3 years, despite a reminder mailed by the health insurance on the previous year (list set up by the health insurance). * Able to understand and sign voluntarily the consent to participate * Warranted by the health insurance * Able to understand and answer the questions of the study questionnaire alone or with the help of a self-chosen third party. Exclusion Criteria: * No vaginal intercourse ever * Pap-test quoted on another budget (hospital, mother and child protection…) conducted less than 3 years ago * Known cervical lesion or known HPV status * History of hysterectomy * History of conisation * History of laser treatment of the cervix * History of cervical cancer * Other medical reason to delay cervical cancer screening * Abroad for more than one year * Moving to another region (done or expected) * Pregnant or breastfeeding * Screening not relevant from the practitioner's perspective (Emergency situation, comorbidity…)
References
Publications (28)
- BACKGROUNDFishbein M. A reasoned action approach to health promotion. Med Decis Making. 2008 Nov-Dec;28(6):834-44. doi: 10.1177/0272989X08326092. Epub 2008 Nov 17. PMID 19015289
- BACKGROUNDvan Baars R, Bosgraaf RP, ter Harmsel BW, Melchers WJ, Quint WG, Bekkers RL. Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women. J Clin Microbiol. 2012 Dec;50(12):3937-43. doi: 10.1128/JCM.01506-12. Epub 2012 Sep 26. PMID 23015677
- BACKGROUNDViguier J, Calazel-Benque A, Eisinger F, Pivot X. Organized colorectal cancer screening programmes: how to optimize efficiency among general practitioners. Eur J Cancer Prev. 2011 Jan;20 Suppl 1:S26-32. doi: 10.1097/01.cej.0000391567.49006.af. PMID 21245677
- BACKGROUNDVerhoef VM, Bosgraaf RP, van Kemenade FJ, Rozendaal L, Heideman DA, Hesselink AT, Bekkers RL, Steenbergen RD, Massuger LF, Melchers WJ, Bulten J, Overbeek LI, Berkhof J, Snijders PJ, Meijer CJ. Triage by methylation-marker testing versus cytology in women who test HPV-positive on self-collected cervicovaginal specimens (PROHTECT-3): a randomised controlled non-inferiority trial. Lancet Oncol. 2014 Mar;15(3):315-22. doi: 10.1016/S1470-2045(14)70019-1. Epub 2014 Feb 13. PMID 24529697
- BACKGROUNDDuport N, Serra D, Goulard H, Bloch J. [Which factors influence screening practices for female cancer in France?]. Rev Epidemiol Sante Publique. 2008 Oct;56(5):303-13. doi: 10.1016/j.respe.2008.07.086. Epub 2008 Oct 31. French. PMID 18951740
- RESULTFavre J, Rochoy M, Raginel T, Pelletier M, Messaadi N, Deken-Delannoy V, Duhamel A, Berkhout C. The Effect of Cervical Smears Performed by General Practitioners on the Cervical Cancer Screening Rate of their Female Patients: A Claim Database Analysis and Cross-Sectional Survey. J Womens Health (Larchmt). 2018 Jul;27(7):933-938. doi: 10.1089/jwh.2017.6656. Epub 2018 Mar 27.