RecruitingNot ApplicableNCT07480902

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

Sponsor

Timser SAPI de CV

Enrollment

558 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

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

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods for detecting precancerous changes and cervical cancer: the traditional liquid-based cell test (similar to a Pap smear) versus a newer molecular screening test. Researchers want to find out which approach catches more problems early, which is key to preventing cervical cancer. **You may be eligible if...** - You are between 18 and 85 years old - You are in good general health - You are willing to avoid sexual intercourse for 24 hours before the study - You can fast for 6–12 hours before the procedure - You can provide written consent **You may NOT be eligible if...** - You have had a partial or full hysterectomy (uterus removed) - You are pregnant or might be pregnant - You are currently receiving cancer treatment (chemotherapy, radiation, or brachytherapy) - You are on your period - You have a confirmed diagnosis of HIV or hepatitis - You have taken blood-thinning medications (such as aspirin) in the 24 hours before the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPhysical examination

Physical examination and interview for obtaining a medical record of each participant

OTHERLiquid-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

OTHERMolecular 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

OTHERHPV DNA test

HPV DNA detection is performed using a cervical swab

DIAGNOSTIC_TESTColposcopy

A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope

DIAGNOSTIC_TESTHistopathology

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

Locations(1)

Consultorio Médico TIMSER

Mexico City, Mexico City, Mexico

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NCT07480902