Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05026047 |
| Other study ID # |
APHP200078 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2023 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Morgane MAILHE, MD |
| Phone |
+33 1 40 25 78 84 |
| Email |
morgane.mailhe[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Women living with HIV are unsufficiently screened for cervix cancer although they have a
higher risk of developping it, resulting in many obstacles. Offering a new screening
technique, more accessible and which doesn't require gynecologic examination, could help
improving this coverage rate. Human Papillomavirus (HPV) screening have a higher-performance
for cervix cancer than smear test. Self-collected vaginal swabs are as efficient as vaginal
swabs performed by clinicians. They are also shown as acceptable among general population but
only one study in South Africa has been performed on women living with HIV. In addition,
recent studies on urine self-sampling for high risk HPV (HR-HPV) screening report
satisfactory performance. The main hypothesis is that self-collected vaginal swabs and urine
self-sampling are also acceptable among women living with HIV in the CoreVIH Ile de France
Nord (CoreVIH) cohort.
Description:
Worldwide, cervical cancer is the second most common cancer (10% of all cancers), in 2012:
528,000 cases and 266,000 deaths. In France, in 2012, the incidence is estimated at 6.7 per
100,000 women, with 3,028 new cases per year and 1,102 deaths. Screening for cervical cancer
is a public health issue because cancer affects young, healthy women and early detection is
available. Persistent infection with oncogenic HPV (Human Papillomavirus) is responsible for
the development of pre-cancerous lesions and cervical cancer. There are more than a hundred
genotypes of HPV identified. Among them, HPV 16 and 18 are the genotypes most often
associated with cancer. The natural history of cervical cancer has led to the definition of
several ways to prevent the development of cancer, such as vaccination to prevent infection,
screening for infection using HPV virological tests that detect DNA, and cervical smears to
detect precancerous or cancerous lesions. In France, in the general population, screening is
done by smear test performed by a clinician or in a biological laboratory for cytological
analysis. The recommendations of the French Health Authority (HAS) are to perform a smear
test every three years, after two normal smears one year apart from 25 to 65 years of age,
except in women who have never had sexual intercourse and those who have had a hysterectomy
with removal of the cervix. Since July 2019, the HAS has introduced in its recommendations
for cervical cancer screening the use of HPV testing, which must now replace the cytological
examination from the age of 30 years and must be performed 3 years after the last cytological
examination with a normal result and then every 5 years in case of negativity.
This test can be offered as a vaginal self-sampling for women who are not or insufficiently
screened. Women living with HIV are part of this population and are included in these
recommendations. Other countries such as the Netherlands have included virological analysis
in their strategy: in 2011 the health authorities have decided to use HPV self-tests in
primary care instead of cervical smear tests (FCU). In 2016, the recommendation in the
Netherlands is to perform an HPV test every 5 years from 30 to 60 years of age. In case of a
positive HPV test, an FCU is performed.
Virological tests can be carried out on vaginal swabs by hetero or self-sampling or on urine
samples. In HIV patients, earlier screening is recommended because of the increased risk of
developing cancerous lesions as a result of immunosuppression. The Morlat report (2013)
recommends an annual smear test as soon as seropositivity is discovered, with no upper age
limit. France has individual and unorganized screening (such as breast or colon cancer) with
incomplete coverage. According to HAS data in 2010, only 8% of women eligible for smear
screening have an adequate follow-up rate. 52% of women aged 25-65 are not screened at all or
have smears too far apart (more than 3 years). A majority of cases of cervical cancer are
diagnosed in France in women participating irregularly or not participating in individual
screening. The tests are based on the detection of HPV on a sample of the cervix. The
virological technique is already recommended in the triage of smear test with atypical
squamous cells of undetermined significance (ASC-US). Several types of self-samples are
currently available. Studies show a good level of agreement for all vaginal swabs using HPV
testing by polymerase chain reaction (PCR) technique (dry swab, swab with liquid transport
medium). The different studies that have tested the acceptability of HPV self-sampling in the
general population show good acceptability; between 66 and 94% acceptability depending on the
studies.
The use could be interesting in the first instance to catch up with women who have not been
screened due to the hindrance of gynaecological examination or the constraint of a medical
consultation. In a French study, the APACHE project, the proposal of self-sampling in
unscreened women had increased participation in cervical cancer screening. The use of
self-sampling improves participation in screening by sending the kits to women who are not
up-to-date in their smear test. In a study conducted among HIV-infected women in South Africa
in 2015, there was 90% acceptability.
The APACHE project is a series of studies carried out in France between 2009 and 2014 on the
subject whose two objectives were to evaluate the performance of self-sampling for the
detection of cervical HPV infection and to assess the effectiveness on participation of
sending a self-sampling kit to the homes of undetected women.
A previous medical thesis showed that 54% of patients followed up at the CoreVIH Ile de
France Nord had a smear that was less than two years old (9). The idea is therefore to
explore alternative options for these women who are being followed at CoreVIH Ile de France
Nord but who are not being screened at the recommended rate.
