Status:
NOT_YET_RECRUITING
Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population
Lead Sponsor:
Timser SAPI de CV
Conditions:
Atypical Squamous Cell of Undetermined Significance
ASC-US
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
This study compares the efficacy of cytology (Pap smear) with the molecular screening in their ability to detect reactive cellular changes in the cervix among an open population
Detailed Description
The primary goal of this study is to compare the efficacy of the cytology (Pap smear) with the molecular screening -of three human biomarkers- in their ability to detect reactive cellular changes in t...
Eligibility Criteria
Inclusion
- Be in good general health.
- Age 18-85 years.
- A minimum fast of 6 hours and no more than 12 hours.
- Refrain from sexual intercourse 24 hours before the study.
- Give written informed consent.
Exclusion
- Having a subtotal, total, or radical hysterectomy.
- Being pregnant or suspected of being pregnant. A rapid urine test will be performed. If the result is positive, the patient will be excluded from the protocol and referred for prenatal care.
- Being under oncological treatment (chemotherapy, radiotherapy and/or brachytherapy).
- Being on their period.
- Have a previous confirmatory diagnosis of HIV and/or hepatitis infection.
- Having taken antiplatelet medications, e.g., acetylsalicylic acid, at least 24 hours before the study.
- Discontinuation Criteria:
- If the participant refuses any of the study procedures.
- If the study gynecologist detects that the participant has had a hysterectomy.
- If the volume of the biological samples is insufficient (less than 10 mL for the blood sample).
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07211204
Start Date
November 1 2025
End Date
September 1 2026
Last Update
October 7 2025
Active Locations (1)
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1
Clinica Reina Madre Metepec
San Mateo Atenco, State of Mexico, Mexico, 52105