Human Papillomavirus (HPV)-Related Cervical CancerXyto-RoNCT04520464
Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider (Xyto-Ro)
A study testing Cervical samples for identification of HR-HPV DNA via real-time PCTR. in people with Human Papillomavirus (HPV)-Related Cervical Cancer and HPV DNA, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Human Papillomavirus (HPV)-Related Cervical Cancer, HPV DNA
- What is being tested?
- Cervical samples for identification of HR-HPV DNA via real-time PCTR.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2020to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Cervical samples for identification of HR-HPV DNA via real-time PCTR.
- Keywords
- CINtec Plus., Pap test., Progression to high-grade injury., Xylo test.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical samples for identification of HR-HPV DNA via real-time PCTR.Diagnostic test
Identification of HR-HPV DNA via real-time PCTR.
| Study group | Role | What they receive |
|---|---|---|
| Self-test for cervical sample | Active comparator | First sequence will start with self-test. Second sequence will start with traditional method. Receives: 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. Receives: Diagnostic Test: Cervical samples for identification of HR-HPV DNA via real-time PCTR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
Acceptability for self-test
A survey will be applied to assess self-test acceptability in comparison to direct sampling by service provider
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV)-Related Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomly selected by two sequences which will be used for diagnostic and positive patients will be referred for colposcopy and biopsy.
- Masking
- None (open label)
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Carlos E. Aranda Flores, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Luis M Molina Fernández de Lara, PhD, Study chair, Hospital General de México Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520464
- Sponsor's protocol ID
- DI/16/111/03/001
- Acronym
- Xyto-Ro
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04520464
- Acronym / sponsor ID
- Xyto-Ro / DI/16/111/03/001
- Keywords
- CINtec Plus., Pap test., Progression to high-grade injury., Xylo test.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly selected by two sequences which will be used for diagnostic and positive patients will be referred for colposcopy and biopsy.
| Arm | Type | Receives |
|---|---|---|
| Self-test for cervical sample | Active comparator | Diagnostic Test: Cervical samples for identification of HR-HPV DNA via real-time PCTR.First sequence will start with self-test. Second sequence will start with traditional method. |
| Traditional provider for cervical sample | Active comparator | Diagnostic Test: Cervical samples for identification of HR-HPV DNA via real-time PCTR.First sequence will start with traditional method. Second sequence will start with self-test method. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical samples for identification of HR-HPV DNA via real-time PCTR.Identification of HR-HPV DNA via real-time PCTR. | Diagnostic test | Self-test for cervical sample, Traditional provider for cervical sample |
Primary outcome
To assess effectiveness of cervicovaginal diagnosis by self-test in comparison with direct sampling by the service provider.
Time frame: 5 months
Identification of HPV-HR DNA via real-time PCTR and triage with dual-staining biomarker p16 \& ki67.
1 secondary outcome
Acceptability for self-test
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis M Molina Fernández de Lara, PhD study chair
Hospital General de México Eduardo Liceaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical samples for identification of HR-HPV DNA via real-time PCTR. in people with Human Papillomavirus (HPV)-Related Cervical Cancer and HPV DNA, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos E Aranda Flores, Oncology ((52) 55 2789 2000 ext. 1420, aranda_floresc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess effectiveness of cervicovaginal diagnosis by self-test in comparison with direct sampling by the service provider. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.