Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner

Cervical Intraepithelial Neoplasia Clinical Trial

— PaCUDAHL-Gé  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749110
• Other study ID #: 2015_08
• Secondary ID: 2015-A01331-48LI
• Status: Completed
• Phase: N/A
• Start date: August 28, 2016
• Est. completion date: February 23, 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In France screening for cervical cancer (CC) is usually based on an opportunistic screening program. French guidance recommends performing a smear every 3 years from the age of 25 to 65 years, after 2 initial normal yearly smears. Pap-tests can be carried out by medical doctors or midwifes. The coverage rate is estimated between 56.6% and 83.0%. In deprived populations, about 55% of women are unscreened as their risk to develop a CC is majored. The gynecologic examination and the consultation of a gynecologist appear to be the main barriers to the pap-test. Almost all these unscreened women visit their family physician at least yearly for themselves or with a relative, but many family physicians do not perform pap-tests. Our hypothesis is that more women are to be screened if they are invited to by their family physician (who carries out the pap-test himself or who refers the woman to a gynecologist or a midwife), and that the screening rate will be majored if the family physician delivers to his female patients, who are not willing to undergo a pap-smear, a vaginal self-sampling device.

To demonstrate this, we will conduct an open label 1:1 cluster randomized controlled trial. As the gender of the physician and his ability to carry out pap-tests is associated to the rate of his listed screened female patients, randomization will be stratified on these two variables. The 24 participating physicians (12 in each study arm) will enroll 2000 unscreened female patients. The study population will be all the social security insured unscreened listed women aged from 30 to 65 years of the participating physicians. As the specificity of the HPV-test to screen for CC is insufficient before the age of 30, woman between 25 and 29 years of age will not be part of the study.

All these women (unless an exclusion criterion appears in their medical record) will receive from their family physician an invitation letter to make an appointment for an encounter dedicated to CC screening. Women who accept to be enrolled in the study will sign a consent form and will be invited to fill in a questionnaire about their socio-economic profile and their beliefs and attitudes about prevention, cancer screening in general and screening for CC in particular. Participation to the screening process is not necessary for inclusion. Women in the control arm will be solely proposed to undergo a pap-test performed by their family physician or a gynecologist or a midwife. Women in the intervention arm will be alternatively proposed to proceed to an at home performed vaginal self-collection of a sample that is to be send by post to a centralized lab for HPV testing. HPV tests will be conducted by the virology lab of the University Hospital of Lille.

All screened negative women in both arms of the study will be considered as successful outcomes and finish the study. HPV screened positive women from the self-collection arm will be proposed a triage pap-test or colposcopy. Further 18 months follow-up will be matching French guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: February 23, 2021
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Malignant Tumor of Cervix
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

Device:
• Vaginal self-sampling brush
Self-collection by unscreened women aged from 30 to 65 of a vaginal sample with the device. After collection, the whole device is mailed in a normalized for biological samples package to the virology lab of the University Hospital of Lille where a HPV test is conducted using a Cobas 4800 technique.

Locations

Country	Name	City	State
France	Doctor's office 115	Herzeele

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (26)

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TOMBOLA Group. Cytological surveillance compared with immediate referral for colposcopy in management of women with low grade cervical abnormalities: multicentre randomised controlled trial. BMJ. 2009 Jul 28;339:b2546. doi: 10.1136/bmj.b2546. — View Citation

van 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. — View Citation

Verhoef 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. — View Citation

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Zehbe I, Moeller H, Severini A, Weaver B, Escott N, Bell C, Crawford S, Bannon D, Paavola N. Feasibility of self-sampling and human papillomavirus testing for cervical cancer screening in First Nation women from Northwest Ontario, Canada: a pilot study. B — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	European Deprivation Index (EDI) associated to the dwelling of the study subjects	The EDI is an index based on 8 demographic determinants	At baseline
Primary	Rate of women terminating the whole diagnostic process.	Women participating in the study but refusing the screening process are considered as "failure	For screening: 12 months; for follow-up of screened positive subjets: 18 months
Secondary	Theory of planned behavior (TPB) see Ajzen-Fishbein	Data collected by self-completed questionnaire.psychological determinants of screening in 7 groups of variables (Attitudes, norms, Self-efficacy, intention, environmental factors, skills and abilities, behavior)	At baseline
Secondary	social determinants of screening (age, level of education, level of resources, vocational situation, matrimonial status…)	Data collected by self-completed questionnaire	At baseline