This study is to answer two questions. First the reliability and validity of the novel lavage method to screen on cervical cancer in combination with the clinically validated hrHPV and hypermethylation triage tests. Second the functionality and…
ID
Source
Brief title
Condition
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* To assess the reliability of MySample (MySample BV, the Netherlands) used in
home-setting, for hrHPV testing and methylation triage (HPV-Risk Assay and
QIAsure Methylation test, Selfscreen, the Netherlands), using the
clinician-collected brush as comparative method by calculating percent
agreement and the kappa, stratified for CIN2+/CIN3+.
* To clinically validate specimens self-collected with MySample by evaluating
the sensitivity of hrHPV primary (HPV risk assay) for identifying CIN2+/CIN3+,
as confirmed by colposcopy and biopsy. The relative sensitivity of hrHPV
testing on MySample self-samples must be at least 90% compared to that of hrHPV
testing on the clinician-collected brush samples as determined with the
non-inferiority score test.
Secondary outcome
* To compare the sensitivity and specificity of methylation triage (HPV-Risk in
combination with QIAsure Methylation test) and the specificity of primary hrHPV
testing (HPV-Rrisk assay) between the MySample specimens and
clinician-collected specimens for identifying CIN2+ and CIN3+, as confirmed by
colposcopy and biopsy.
* To evaluate the acceptability of MySample compared to the pelvic examination;
* To evaluate the Instructions for Use;
* To evaluate the functionality of the novel MySample: the assembly of bottle
to inserter, technical complaints;
* To evaluate the acceptance, and validate the procedure to handle, store,
process the specimen in the laboratory;
* To measure the volume of fluid collected with MySample;
* To measure pellet size;
* To compare the percentage of indeterminate or insufficient specimen
collections between MySample and clinician-collected specimens by b-globin
testing;
* To record any adverse event that occurs from use of the device, as a
measurement of safety.
Background summary
Self-collection of cervicovaginal cells by lavage has been proved to give
reliable results in HPV-screening on cervical cancer. Self-collection has been
proved to increase the participation rate of women in screening programs and
contributes to a substantial higher detection of women at risk of cervical
cancer.
A novel lavage method, the MySample (MySample BV), is designed to improve the
ease of use and comfort at use for women while keeping the lavage method itself
unchanged.
Study objective
This study is to answer two questions. First the reliability and validity of
the novel lavage method to screen on cervical cancer in combination with the
clinically validated hrHPV and hypermethylation triage tests. Second the
functionality and acceptance of MySample, evaluated by the users (women and
laboratory).
Study design
An anticipated 60 colposcopy with CIN2+ and 140 healthy volunteers in the age
of 30-65 years old with an appointment at the gynecology outpatient department
are invited to participate in the study. The colposcopy referrals will receive
the self-sampler at an extra inclusion visit that takes place before
colposcopy. The healthy volunteers will receive the self-sampler at home.
Participants will collect a lavage sample at home and are requested to complete
pre- and post-use questionnaires addressing the ease of use, degree of comfort,
confidence and preference. Participants will also complete a technical
questionnaire addressing the functionality of the novel device. In addition to
a self-collected lavage specimen a clinician will collect a cervical smear at
the hospital. The test results of the cervical specimen will be compared with
those of the lavage specimen.
All collected specimens are sent to Self-screen B.V. labratorium (part of VU
medical Center Amsterdam). Both the lavage and clinician-obtained specimen will
get different patient codes to assure blinding of paired specimens. The
laboratory will measure volume and pellet size of the lavage specimen. On both
specimens the lab will test on hrHPV and beta-globin for quality control. All
hrHPV positive specimens will subsequently be tested on methylation (triage).
The outcome on both lavage and clinician specimen will be compared with each
other.
All colposcopy test results collected within the study period will be included
in the analysis. The lavage and clinician specimens will be compared on the
sensitivity and specificity to identify CIN2+ women.
Intervention
nvt
Study burden and risks
Not applicable
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
* Colposcopy referral (> PAP 3A2 in the cervical cancer screening program, or at the gynecological outpatient department ) or healthy volunteer.
* Scheduled appointment at the gynecological outpatient department of the participating hospital;
* Between 30 and 65 years old;
* Self-report being able to read in Dutch;
* Willing to sign Informed Consent;
Exclusion criteria
* No uterus / history of complete hysterectomy;
* No previous treatment for CIN 2/CIN 3
* healthy volunteers; positive PAP-smear in the last 5 years.
* Mental or physical handicap that would prevent self-collection of specimens;* Women are not allowed to use the self-sampling device when they are menstruating. Participants who are having their period between recruitment and the scheduled appointment will be instructed to take this into consideration, allowing at least one week interval between self-collection and hospital visit.
* Women who use vaginal products (douche, spermicide, antifungal) will be instructed to wait for 48 hours before using the device. This does not include water-based lubricants or condoms and the NuvaRing.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55570.015.15 |