NCT03183700

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

May 16, 2017

Last Update Submit

July 16, 2018

Conditions

Cervical Cancer

Keywords

Screening HPVSelf samplingDNA Methylation

Outcome Measures

Primary Outcomes (1)

  • hrHPV self-sampling test

    Effects of a hrHPV self-sampling test as strategies to reach non-attending women in organized cervical screening

    14 months

Secondary Outcomes (1)

  • Evaluation of collection and storing performance of two self sampling devices

    14 months

Other Outcomes (1)

  • Evaluation of the best triage strategy for self samples

    14 months

Study Arms (3)

Control arm 1

OTHER

The women will receive the usual recall with a new invitation letter with a prefixed appointment.

Other: Cervical ThinPrep sampling

Intervention arm 2

EXPERIMENTAL

Dry one, where FloqSwab, with which perform the sampling is contained and will be preserved after sampling in a tube without preservation solutions

Device: Self sampling device

Intervention arm 3

EXPERIMENTAL

Wet one in which, after sampling, the FloqSwab, will be dissolved in preservation solutions.

Device: Self sampling device

Interventions

Self sampling deviceDEVICE

The investigators will allocate randomly the women to two different self sampling devices differing in having or not a preservative buffer

Intervention arm 2Intervention arm 3
Cervical ThinPrep samplingOTHER

Women are inviated with a standard invitation letter to perform cervical ThinPrep sampling at the clinic on a pre-fixed date

Control arm 1

Eligibility Criteria

Age34 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Not responding to the previous screening round

You may not qualify if:

  • Had any cervical smears taken for \< 3 years
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Prevention and Research Institute, ISPO

Florence, FI, 50139, Italy

RECRUITING

Related Publications (8)

  • Giorgi 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: 21179038BACKGROUND

  • Gok 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: 20223872BACKGROUND

  • Gok 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: 21484793BACKGROUND

  • Hesselink 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: 21389098BACKGROUND

  • Holanda 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: 16997304BACKGROUND

  • Igidbashian 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.

    PMID: 21351869BACKGROUND

  • Khanna N, Mishra SI, Tian G, Tan MT, Arnold S, Lee C, Ramachandran S, Bell L, Baquet CR, Lorincz A. Human papillomavirus detection in self-collected vaginal specimens and matched clinician-collected cervical specimens. Int J Gynecol Cancer. 2007 May-Jun;17(3):615-22. doi: 10.1111/j.1525-1438.2006.00835.x.

    PMID: 17504376BACKGROUND

  • Lazcano-Ponce E, Lorincz AT, Cruz-Valdez A, Salmeron J, Uribe P, Velasco-Mondragon E, Nevarez PH, Acosta RD, Hernandez-Avila M. Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial. Lancet. 2011 Nov 26;378(9806):1868-73. doi: 10.1016/S0140-6736(11)61522-5. Epub 2011 Nov 1.

    PMID: 22051739BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Francesca M Carozzi, PhD

    Cancer prevention and Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca M Carozzi, PhD

CONTACT

+39 05532697852f.carozzi@ispo.toscana.it

Cristina Sani, Dr

CONTACT

c.sani@ispo.toscana.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biologist Director

Study Record Dates

First Submitted

May 16, 2017

First Posted

June 12, 2017

Study Start

August 9, 2016

Primary Completion

August 9, 2017

Study Completion

August 9, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

IT(1)