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

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

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

PROCEDURE

Physical examination

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

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

Sponsors & Collaborators

• Timser SAPI de CV

  lead INDUSTRY

Principal Investigators

• Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol · Consultorio Médico TIMSER

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-03

Primary Completion

2026-04-30

Completion

2026-06-30

Countries

• Mexico

Study Locations