Cervical Cancer Clinical Trial
Official title:
Cervical And Self-Sample In Screening (CASSIS) Study: Diagnostic Performance of Molecular HPV Testing With the Eve Medical Self-collection System© for Detecting Cervical Intraepithelial Neoplasia
The proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV)
testing in self-collected samples via the Eve Medical self-collection system© (Eve) with
standard physician-collected samples for the detection of cervical intraepithelial neoplasia
grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The
performance of the Eve sample will also be compared with that of a second self-sample via a
cobas® PCR Female swab.
Approximately 1000 adult women with an abnormal Pap test at the level of an atypical
squamous cells of undetermined significance or worse squamous or glandular abnormality
(i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited
over a period of 12 months via colposcopy clinics located at the Jewish General Hospital,
St-Mary's Hospital, and the McGill University Health Centers (Royal Victoria Hospital).
Participating women will undergo three cervical or cervicovaginal sampling techniques: 1)
self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas®
PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a
questionnaire on their experience with the convenience and acceptability of the Eve system,
relative to the other two sampling approaches. The decision as to which self-sample is to be
collected first will be dependent on randomization
HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the
cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media
with the two self-collected samples will be used to suspend the cellular material prior to
HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the
Department of Clinical Microbiology at the McGill University Health Centre for the HPV
genotyping work.
Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity,
specificity, and predictive values (along with their respective 95% confidence intervals)
will be calculated for each sample type to evaluate the clinical performance of the various
sampling techniques. We will use CIN1+ as definition of disease but analyses will also be
performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.
After the discovery that Human Papillomavirus (HPV) infection is the necessary cause of
cervical cancer there have been much interest in the introduction of novel screening
strategies involving HPV DNA testing [1]. HPV DNA testing was shown to have higher
sensitivity in detecting cervical cancer and its precursors and greater reproducibility than
Papanicolaou (Pap) cytology screening and has been therefore proposed as the primary
screening method for the future. In high-income countries, cases of cervical cancer continue
to develop among unscreened and under-screened women [2]. Factors discouraging women from
attending routine screening include fear of pain or discomfort, lack of time or perceived
inconvenience, cultural or religious concerns, and poor socioeconomic status [3]. For a
screening program to be effective high coverage is essential and thus attendance is a
critical requirement.
Because of the high sensitivity of molecular HPV testing to detect cervical cancer
precursors there is great potential for screening coverage to be increased by inviting
non-attendant to provide self-collected vaginal samples. Providing these women with a
simple, convenient, and inexpensive means of self-testing may improve cervical screening
participation [3]. Self-sampling is also an attractive approach to assist screening in poor
countries, which typically do not have structured cervical cancer screening programs while
having to bear the greatest burden of cervical cancer morbidity and mortality [4].
Self-sampling can also enhance the value of post-HPV vaccination surveillance by allowing a
more efficient monitoring of HPV type distribution in populations. Finally, self-sampling
represents a good research tool to assist prospective studies of genital HPV infection and
natural history of cervical neoplasia.
Specifically for cervical cancer screening, it has been shown that self-collected
cervicovaginal specimens from women who received proper instruction for collecting them
yield HPV test results that are comparable to those in specimens collected by physicians
[5-8]. Women also prefer self-sampling relative to clinician-provided samples, provided that
they can be assured that they are told how to properly collect the sample [8, 9]. Although
there is conceivably some loss of sensitivity and specificity in screening for cervical
cancer in a specimen that is not directly collected from the ecto- and endo-cervix the
overall accuracy of the HPV testing results (to identify presence of cervical precancerous
lesions) is still superior to that of physician-collected Pap smears. Therefore, replacing a
more anatomically-correct specimen (the one collected with direct visualization of the
cervix by a primary healthcare provider) with one collected from the vagina (and thus
diluted with exfoliated cells from a wider epithelial surface area) is compensated by the
high sensitivity of the molecular screening approach [6, 10, 11]. Performance of screening
seems also to be unaffected by storage and transport of the self-sample swabs, irrespective
of whether they have been kept dry or transferred and resuspended into a liquid transport
medium [10, 12].
A critical feature in enhancing women's acceptance and adherence with the self-sampling
approach for cervical cancer screening and HPV surveillance studies is the convenience of
the device used for collection. Dacron and polyester swabs are simple, common, and
inexpensive. However, they are inconvenient and not isolated within a sheath that prevents
contact of the sampling area with mucosal surfaces in the labia and vaginal opening.
Ideally, sampling devices should be anatomically correct to facilitate insertion and the
sampling surface that will retain the exfoliated cells should be protected from contact with
the labia and lower vaginal mucosa while the device is inserted, with the objective of
sampling cells that are mostly from the cervix and upper vaginal area.
HPV DNA testing using self-collected cervicovaginal specimens represents a promising
strategy to increase cervical screening participation and thus reduce rates of cervical
cancer in countries with established cervical screening programs. Furthermore, this approach
can also greatly improve the coverage and quality of cervical cancer screening in developing
countries, as well as in remote regions in developed countries, e.g., aboriginal populations
in Northern Quebec and in First Nations territories. Facilitating and improving uptake of
cervical cancer screening would save lives, reduce costs of treating invasive cancer and
potentially reduce inequalities in avoidable mortality caused from cervical cancer.
(full protocol available upon request)
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Screening
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |