Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population

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

Conditions

• Atypical Squamous Cell of Undetermined Significance
• ASC-US
• Atypical Glandular Cells of Uncertain Significance
• AGUS
• Cervical Intraepithelial Neoplasia (CIN)
• CIN 1
• CIN 2
• CIN 3
• Cervical Cancer

Interventions

PROCEDURE

Physical examination

Physical examination and interview for obtaining a medical record

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.

Sponsors & Collaborators

• Timser SAPI de CV

  lead INDUSTRY

Principal Investigators

• Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol · Clinica Reina Madre Metepec

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

2026-02-27

Primary Completion

2026-02-27

Completion

2026-02-27

Countries

• Mexico

Study Locations