Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner
Condition: Malignant Tumor of Cervix; Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Vaginal self-sampling brush
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Evalyn Brush; European Community (EC) certificate N°: 44232121392
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
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