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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-3IV) 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

Inclusion Criteria5

  • Be in good general health.
  • Age 18-85 years.
  • A minimum fast of 6 hours and no more than 12 hours.
  • Refrain from sexual intercourse 24 hours before the study.
  • Give written informed consent.

Exclusion Criteria10

  • Having a subtotal, total, or radical hysterectomy.
  • Being pregnant or suspected of being pregnant. A rapid urine test will be performed. If the result is positive, the patient will be excluded from the protocol and referred for prenatal care.
  • Being under oncological treatment (chemotherapy, radiotherapy and/or brachytherapy).
  • Being on their period.
  • Have a previous confirmatory diagnosis of HIV and/or hepatitis infection.
  • Having taken antiplatelet medications, e.g., acetylsalicylic acid, at least 24 hours before the study.
  • Discontinuation Criteria:
  • If the participant refuses any of the study procedures.
  • If the study gynecologist detects that the participant has had a hysterectomy.
  • If the volume of the biological samples is insufficient for testing.

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