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Trial record 14 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

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

This study is currently recruiting participants.
Verified September 2016 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT02749110
First Posted: April 22, 2016
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
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.

Condition Intervention
Malignant Tumor of Cervix Cervical Intraepithelial Neoplasia Device: Vaginal self-sampling brush

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Rate of women terminating the whole diagnostic process. [ Time Frame: For screening: 12 months; for follow-up of screened positive subjets: 18 months ]
    Women participating in the study but refusing the screening process are considered as "failure


Secondary Outcome Measures:
  • Theory of planned behavior (TPB) see Ajzen-Fishbein [ Time Frame: At baseline ]
    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)

  • social determinants of screening (age, level of education, level of resources, vocational situation, matrimonial status…) [ Time Frame: At baseline ]
    Data collected by self-completed questionnaire


Other Outcome Measures:
  • European Deprivation Index (EDI) associated to the dwelling of the study subjects [ Time Frame: At baseline ]
    The EDI is an index based on 8 demographic determinants


Estimated Enrollment: 2000
Study Start Date: August 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-sampling for HPV test
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
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 Names:
  • Evalyn Brush
  • European Community (EC) certificate N°: 44232121392
No Intervention: Usual care (Pap test)
Intervention: invitation to participate to the screening process by means of the usual care (pap-test).

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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…)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749110


Contacts
Contact: Christophe Berkhout christophe.berkhout@univ-lille2.fr

Locations
France
Doctor's office 115 Recruiting
Herzeele, France
Principal Investigator: Stephan Creton, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Principal Investigator: Christophe Berkhout, MD University Hospital, Lille
  More Information

Publications:

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02749110     History of Changes
Other Study ID Numbers: 2015_08
2015-A01331-48 ( Other Identifier: ID-RCB number, ANSM )
LIC-14-14-0615 ( Other Identifier: PREPS number, DGOS )
First Submitted: April 20, 2016
First Posted: April 22, 2016
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
Early detection of cancer/methods*
Mass screening
Family medicine
Human Papillomavirus DNA tests
Papanicolaou test
Specimen Handling/methods*
Patient compliance
Adult
Female
Humans
Randomized controlled trial

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma in Situ
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma