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

NCT04520464 | Unknown

• 1 other identifier: DI/16/111/03/001
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CINtec Plus.; Pap test.; Progression to high-grade injury.; Xylo test.

Outcome Measures

Primary Outcomes (1)

• To assess effectiveness of cervicovaginal diagnosis by self-test in comparison with direct sampling by the service provider.

  Identification of HPV-HR DNA via real-time PCTR and triage with dual-staining biomarker p16 \& ki67.

  5 months

Secondary Outcomes (1)

• Acceptability for self-test

  5 months

Study Arms (2)

Self-test for cervical sample

ACTIVE COMPARATOR

First sequence will start with self-test. Second sequence will start with traditional method.

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

Traditional provider for cervical sample

ACTIVE COMPARATOR

First sequence will start with traditional method. Second sequence will start with self-test method.

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

Interventions

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

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

Self-test for cervical sample; Traditional provider for cervical sample

Eligibility Criteria

• Age: 25 Years - 64 Years
• Gender Eligibility Details: Cervical samples
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

Study Sites (1)

Hospital General de México Eduardo Liceaga

Mexico City, 06720, Mexico

Location

Study Officials

• Luis M Molina Fernández de Lara, PhD

  Hospital General de México Eduardo Liceaga

  STUDY CHAIR

Central Study Contacts

Carlos E Aranda Flores, Oncology

CONTACT

(52) 55 2789 2000; aranda_floresc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon, specialty in oncology

Model Details: Patients will be randomly selected by two sequences which will be used for diagnostic and positive patients will be referred for colposcopy and biopsy.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: October 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)