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

NCT02749110 | Completed

• 3 other identifiers: 2015_082015-A01331-48LIC-14-14-0615
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Tumor of Cervix; Cervical Intraepithelial Neoplasia

Keywords

Mass screening; Family medicine; Human Papillomavirus DNA tests; Papanicolaou test; Early detection of cancer/methods*; Specimen Handling/methods*; Patient compliance; Adult; Female; Humans; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Theory of planned behavior (TPB) see Ajzen-Fishbein

  At baseline

• social determinants of screening (age, level of education, level of resources, vocational situation, matrimonial status…)

  At baseline

Other Outcomes (1)

• European Deprivation Index (EDI) associated to the dwelling of the study subjects

  At baseline

Study Arms (2)

Self-sampling for HPV test

EXPERIMENTAL

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.

Device: Vaginal self-sampling brush

Usual care (Pap test)

NO INTERVENTION

Intervention: invitation to participate to the screening process by means of the usual care (pap-test).

Interventions

Vaginal self-sampling brush DEVICE

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.

Also known as: Evalyn Brush, European Community (EC) certificate N°: 44232121392

Self-sampling for HPV test

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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…)

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Doctor's office 115

Herzeele, France

Location

Related Publications (28)

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Patient Compliance

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christophe Berkhout, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: August 28, 2016
• Primary Completion: August 23, 2019
• Study Completion: February 23, 2021
• Last Updated: February 5, 2026

Record last verified: 2020-08

Locations

FR (1)