Clinical trial · Interventional
Self Collected Sampling in Non-attendees Cervical Cancer Screening: DNA Test and Molecular Triage for HPV Positive Women
The Value of HPV DNA Testing Using Self-collected Sampling in Non Attendees Cervical Cancer Screening and Molecular Triage Strategies on Self-sampled Material for HPV Positive Women.
- 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)
The aims of the present study are to assess the effects of a hrHPV self-sampling test as strategies to reach non-attending women in organized cervical screening in comparison with standard recall by letter in 8000 women; to evaluate the performance of two self sampling devices with and without a preservative buffer and to explore their acceptability among invited women and to evaluate a molecular triage approach for management of HPV positive women in self sampling collected material by HPV genotyping and DNA methylation marker panel
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical ThinPrep sampling | Other | — | UNRESOLVED |
| Self sampling device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Control arm 1
- description
- The women will receive the usual recall with a new invitation letter with a prefixed appointment.
- interventionNames
- Other: Cervical ThinPrep sampling
- type
- EXPERIMENTAL
- label
- Intervention arm 2
- description
- Dry one, where FloqSwab, with which perform the sampling is contained and will be preserved after sampling in a tube without preservation solutions
- interventionNames
- Device: Self sampling device
- type
- EXPERIMENTAL
- label
- Intervention arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 34 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: Not responding to the previous screening round Exclusion Criteria: Had any cervical smears taken for \< 3 years Pregnant
References
Publications (8)
- BACKGROUNDGiorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F; Self-Sampling Study Working Group. The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600). Br J Cancer. 2011 Jan 18;104(2):248-54. doi: 10.1038/sj.bjc.6606040. Epub 2010 Dec 21. PMID 21179038
- BACKGROUNDGok M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, Voorhorst F, Belien JA, Babovic M, Snijders PJ, Meijer CJ. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 2010 Mar 11;340:c1040. doi: 10.1136/bmj.c1040. PMID 20223872
- BACKGROUNDGok M, van Kemenade FJ, Heideman DA, Berkhof J, Rozendaal L, Spruyt JW, Belien JA, Babovic M, Snijders PJ, Meijer CJ. Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. Int J Cancer. 2012 Mar 1;130(5):1128-35. doi: 10.1002/ijc.26128. Epub 2011 May 30. PMID 21484793
- BACKGROUNDHesselink AT, Heideman DA, Steenbergen RD, Coupe VM, Overmeer RM, Rijkaart D, Berkhof J, Meijer CJ, Snijders PJ. Combined promoter methylation analysis of CADM1 and MAL: an objective triage tool for high-risk human papillomavirus DNA-positive women. Clin Cancer Res. 2011 Apr 15;17(8):2459-65. doi: 10.1158/1078-0432.CCR-10-2548. Epub 2011 Mar 9. PMID 21389098
- BACKGROUNDHolanda F Jr, Castelo A, Veras TM, de Almeida FM, Lins MZ, Dores GB. Primary screening for cervical cancer through self sampling. Int J Gynaecol Obstet. 2006 Nov;95(2):179-84. doi: 10.1016/j.ijgo.2006.07.012. Epub 2006 Sep 25. PMID 16997304
- BACKGROUNDIgidbashian S, Boveri S, Spolti N, Radice D, Sandri MT, Sideri M. Self-collected human papillomavirus testing acceptability: comparison of two self-sampling modalities. J Womens Health (Larchmt). 2011 Mar;20(3):397-402. doi: 10.1089/jwh.2010.2189. Epub 2011 Feb 25.