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Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population
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
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 the cervix among an open population. Participants will be asked to attend two study visits. All the clinical procedures will be done on the first visit: 1. Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study. 2. Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions. 3. Venipuncture to obtain a blood sample. 4. Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection. 5. Biopsy, only if the gynecologist detects a cervical lesion or another abnormality during colposcopy. The gynecologist will make preliminary recommendations based on the colposcopic findings. During the second visit the study's gynecologist will explain the tests' results and provide clinical recommendations to each participant. The sensitivity, specificity, and predictive values of cytology, HPV detection, and molecular screening will be calculated using colposcopy (for all participants) and histopathology (for those biopsied). These results will be compared using a DeLong test. Correlation tests will be performed using risk factors data and test results.
Age
18 - 85 years
Sex
FEMALE
Healthy Volunteers
Yes
Clinica Reina Madre Metepec
San Mateo Atenco, State of Mexico, Mexico
Start Date
February 27, 2026
Primary Completion Date
February 27, 2026
Completion Date
February 27, 2026
Last Updated
March 3, 2026
Physical examination
PROCEDURE
Liquid-based cytology
OTHER
Molecular screening
OTHER
HPV DNA test
OTHER
Colposcopy
DIAGNOSTIC_TEST
Histopathology
DIAGNOSTIC_TEST
Lead Sponsor
Timser SAPI de CV
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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