Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520464
Status:
UNKNOWN
Last Update Posted:
2020-08-20
First Post:
2020-08-17
Brief Title:
Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider Xyto-Ro
Sponsor:
Hospital General de México Dr Eduardo Liceaga
Organization:
Hospital General de México Dr Eduardo Liceaga
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Xyto-Ro
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 Womens 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
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 subjects 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 subjects 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
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 subjects 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None