HPV DNA Clinical Trial
Official title:
Non-inferiority Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Sample Collection by the Service Provider for the Identification of HPV-RA DNA and Triage With p16 & ki67 Dual Staining.
Problem Description When cervical cancer screening is needed, the Pap test (or Pap smears) is
still the most common, although there are challenges that continue to prevent effective
screening services in many countries, poor quality testing, long delays until screening is
available, they give the results to women, poor population coverage and insufficient
follow-up treatment. HPV testing can remove barriers related to access to screening services,
since the woman can obtain the sample herself. Women's self-sampling for HPV testing has been
used in a programmatic context in some countries. For a good impact, screening coverage must
reach at least 70% of the target population. In the Region of the Americas, only seven
countries have reported this level of coverage, so there is a great need for improvement.
Several factors make it difficult to improve coverage: most screening programs are
unorganized, available mainly in urban areas, and based on the Pap test, which has been shown
to have low sensitivity, limited and requires multiple consultations.
However, screening alone is not enough to prevent cervical cancer. Follow-up treatment of
women with abnormal screening test results is necessary and remains a challenge.
Main objective To evaluate the effectiveness of cervicovaginal self-test in comparison with
direct sampling by the service provider, for the identification of HR-HPV DNA via real-time
PCTR and triage with dual staining biomarker p16 & ki67.
Methodology Under inclusion and exclusion criteria and signed informed consent, cervical
sample will be taken with the corresponding method according to the randomization (self-test
or service provider) and certify that the device did not cause damage or lacerations in the
vaginal canal. In addition, an acceptability survey will be completed. All women with
positive p16 & ki67 will be referred for colposcopy and biopsy. Patients will be informed her
results with a specialist physician for guidance and indications.
Clinical study design is crossover, monocentric, randomized, open, and non-inferiority.
Statistical differences between self-test and service rpovider will be assesed.
STUDY POPULATION The target population is patients admitted to HGM Oncology Service for
cervical cancer screening through self-sampling and sampling by a service provider. Sample
size is 444 valid patients
PROCESS Visit 1 is an inclusion visit. Participant will be included in the research protocol
in accordance with the inclusion and exclusion criteria established by the protocol, and the
signed informed consent will be collected. Patient will be randomized and sample will also be
taken with the corresponding method and the patient will be completed to certify that the
device did not cause damage or lacerations in the vaginal canal.
Visit 2 will be on the third day after taking the first sample. In this visit, the sample
will be taken with the corresponding method according to the randomization and the patient
will be completed to certify that the device did not cause damage or lacerations in the
vaginal canal. In addition, the acceptability survey will be completed.
Visit 3 will take place 21 calendar days after the second visit, the results will be
delivered to the patient, all women with positive results of CINtec Plus (p16 & ki67) will be
referred for colposcopy and biopsy; said biopsies will be submitted for the analysis of
over-expression of p16 protein. At this last visit, the patient will be informed of the
importance and need to discuss her results with a specialist doctor for guidance and
indications.
STATISTIC ANALYSIS The information to be analyzed are the results and the final diagnosis
obtained by the self-test method (XytoTest device) and the service provider of the Oncology
Service of the Hospital General de México "Eduardo Liceaga".
To determine the non-inferiority of both samples, the Kappa index will be used and to
determine the significance through the Wilcoxon T.
ETHICAL AND BIOSAFETY ASPECTS The study complies with the ethical considerations
corresponding to the 1964 Helsinki World Assembly and with their respective modifications in
the World Medical Assembly, Hong Kong, September 1989 and Edinburgh, Scotland, October 2000
and the Clarification note of Paragraph 29, added by the General Assembly of the WMA,
Washington 2002.
The informed consent format is authorized by the ethics and research committee and strictly
adhere to the general health law and its regulations on research and the guidelines of the
international conference on Harmonization (ICH) on good clinical practice ( GCP).
The subject is considered enrolled in the study when they have signed the informed consent
form, no form must be completed or any research or study procedure must be completed before
obtaining the written informed consent.
Any decision that might influence the subject's decision to remain in the study should be
made known to investigator immediately.
Confidentiality of the subject will be maintained, all persons involved in the research who
have access to the information, are obliged to refrain from disclosing the subject's
information or any personal information.
This study is subject to be audited by Mexican regulatory authorities, with or without prior
notice to the research site.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01860963 -
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N/A |