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Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

NCT02255084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3612

Last updated 2025-12-22

No results posted yet for this study

Summary

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.

Conditions

  • Cancer Cervix

Interventions

BEHAVIORAL

Group 1 remove self sample kit at gp consulting room or perform pap smear

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.

BEHAVIORAL

Group 2 perform self sample at home or pap smear

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.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Ken HAGUENOER, MD-PHD · Centre de coordination des dépistages des cancers, Tours, France

  • Somany SENGCHANH, MD-PHD · Centre de coordination des dépistages des cancers, Tours, France

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255084 on ClinicalTrials.gov