NCT07480902

Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer

Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 558 (estimated)
• Sponsor: Timser SAPI de CV · Industry
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study compares how effective is the molecular screening (a blood test) using Pap smear as reference, that is, a comparison of these tests abilities to detect precursor lesions and cervical cancer among women of an open population

Detailed description

The primary goal of this study is to compare the efficacy of liquid-based 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 liquid-based 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.

Conditions

• I) Atypical Squamous Cells of Undetermined Significance (ASC-US)
• II) Atypical Glandular Cells of Uncertain Significance (AGUS)
• III) Cervical Intraepithelial Neoplasia (CIN), CIN-1, CIN-2, CIN-3
• IV) Low-grade Squamous Intraepithelial Lesion (LSIL)
• V) High-grade Squamous Intraepithelial Lesion (HSIL)
• VI) Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	Physical examination	Physical examination and interview for obtaining a medical record of each participant
OTHER	Liquid-based cytology	Screening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope
OTHER	Molecular screening	The molecular screening detects three human biomarkers associated with cervical precursor lesions and/or cervical cancer. Biomarker detection is done by Western blot and ELISA in human sera
OTHER	HPV DNA test	HPV DNA detection is performed using a cervical swab
DIAGNOSTIC_TEST	Colposcopy	A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope
DIAGNOSTIC_TEST	Histopathology	Is the definitive diagnosis of cervical precursor lesions and cervical cancer. It is the microscopic study of diseased cells and tissues stained with hematoxylin and eosin

Timeline

• Start date: 2026-02-03
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Mexico