Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner (PaCUDAHL-Gé)
|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.|
|ClinicalTrials.gov Identifier: NCT02749110|
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Tumor of Cervix Cervical Intraepithelial Neoplasia||Device: Vaginal self-sampling brush||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 28, 2016|
|Estimated Primary Completion Date :||February 2026|
|Estimated Study Completion Date :||February 2026|
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.
No Intervention: Usual care (Pap test)
Intervention: invitation to participate to the screening process by means of the usual care (pap-test).
- 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
- 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
- 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
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
|Contact: Christophe Berkhoutfirstname.lastname@example.org|
|Doctor's office 115||Recruiting|
|Principal Investigator: Stephan Creton, MD|
|Principal Investigator:||Christophe Berkhout, MD||University Hospital, Lille|