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

NCT04520464 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2020-08-20

No results posted yet for this study

Summary

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.

Conditions

  • Human Papillomavirus (HPV)-Related Cervical Cancer
  • HPV DNA

Interventions

DIAGNOSTIC_TEST

Cervical samples for identification of HR-HPV DNA via real-time PCTR.

Identification of HR-HPV DNA via real-time PCTR.

Sponsors & Collaborators

  • Hospital General de México Dr. Eduardo Liceaga

    lead OTHER_GOV

Principal Investigators

  • Luis M Molina Fernández de Lara, PhD · Hospital General de México Eduardo Liceaga

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-07-31
Completion
2021-10-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04520464 on ClinicalTrials.gov