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Further invitation to attend for cervical cytology

Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)

A further invitation to attend for cervical cytology are going to be sent by mail to women

Attending for cervical cytology

Kit for self-collected vaginal sample are going to be directly sent at women's home

Kit for Self-collected vaginal sample

Ken HAGUENOER

Scientific Context:

High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.

The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.

Description of the project :

Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:

* Intervention arm 1:

Women will receive a further invitation to make a cervical smear

* Intervention arm 2:

Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).

For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.

* Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.

Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample

Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action.

Are considered as whole screening action:

* cervical smear
* HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV)
* HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear

Analysis in sub-groups in order to compare the efficacy of interventions according to :

* The age
* Health insurance system
* Distribution map (urban area, peri-urban area, rural area)

Identify the psychological determinants and mechanisms (checks and motivational factors) that can affect enrollment to the screening procedure for self-collection vaginal sample or cervical smear.

Nine months after the beginning of the study, a questionnaire will be send to the 6000 women.

University Hospital, Tours

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Arthritis

Spondylitis

Rheumatic Diseases

Spondylarthritis

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Joint Diseases

Female patients (18 to 65 years old) with spondyloarthritis or rheumatoid arthritis will undergo HPV screening and a have a close gynecologic follow-up.

Cervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89.

Cervical smear

Pregnancy test

Sexual activity questionnary

Fabienne COURY-LUCAS, MD

Gery Lamblin, MD

Gery Lamblin

Emmanuelle VIGNOT, MD

Emmanuelle Vignot, MD

Fabienne Coury-lucas, MD

Muriel PIPERNO, MD

Jean-Paul LARBRE, MD

Nathalie HOEN, MD

Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of SpondyloArthritis International Society (ASAS) 2009 respectively. In patients whose pathology is resistant to first-line treatment, such as methotrexate for rheumatoid arthritis and peripheral spondyloarthritis, or non-steroidal anti-inflammatory drugs for axial spondyloarthritis, the treatment is based on biotherapies, such as anti-inflammatory drugs. -TNF, to obtain effective control of the disease and prevent joint damage.

Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.

In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.

Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.

Papillomavirus Load in Rheumatic Inflammatory Diseases

Papillomavirus chronic load is defined as a positive HPV test at the end of the study combined with at least 3 positive HPV tests during the 24 months follow-up.

Number of patients with a positive HPV test at enrollment

Number of patients with a negative HPV test at enrollment and having at least one positive HPV test during the 24 months follow-up

Number of patients with a positive HPV test at enrollment and having a negative HPV test at the end of the study.

Number of patients with low-grade and high-grade cytological abnormalities during follow-up among those who had normal cytology at enrollment.

Number of patients ,with normal cytology at enrollment, whose cervical smear indicates a regression in cytological abnormalities or a persistence of cytological abnormalities or a development of abnormalities into cervical cancer or dysplasia, during the 24 months follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention	NCT01588301	Cervical Cancer Human Papilloma...	Attending for c... Kit for Self-co...	30 Years - 65 Years	University Hospital, Tours
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention	NCT01588301	Cervical Cancer Human Papilloma...	Attending for c... Kit for Self-co...	30 Years - 65 Years	University Hospital, Tours
Papillomavirus Load in Rheumatic Inflammatory Diseases	NCT03713736	Spondyloarthrit... Rhumatoid Arthi...	Cervical smear Pregnancy test Sexual activity...	18 Years - 65 Years	Hospices Civils de Lyon
Papillomavirus Load in Rheumatic Inflammatory Diseases	NCT03713736	Spondyloarthrit... Rhumatoid Arthi...	Cervical smear Pregnancy test Sexual activity...	18 Years - 65 Years	Hospices Civils de Lyon
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention	NCT01588301	Cervical Cancer Human Papilloma...	Attending for c... Kit for Self-co...	30 Years - 65 Years	University Hospital, Tours

Spots Global Cancer Trial Database for cervical smear