Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider (Xyto-Ro)
Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider (Xyto-Ro)
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.
Inclusion Criteria:

 -  Signature of informed consent

 -  Women with an active sex life

 -  Women 25 to 64 years old

 -  Patients without hysterectomy, conization of the cervix.

 -  Patients without radiotherapy treatment, cervical chemotherapy.

 -  24 hours before taking the sample, they should not use douches, ovules, lubricants or
 gels.

 Exclusion Criteria:

 -  Patients who have not started a sexual life

 -  Patients with uterine surgery.

 -  Patients pregnant.

 -  Patients with vaginal bleeding.

 -  Patients who have had sexual activity 24 hours prior to taking the sample.