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

Timser SAPI de CV

Status

Not yet enrolling

Conditions

Cervical Intraepithelial Neoplasia (CIN)

CIN 2

Atypical Squamous Cell of Undetermined Significance

CIN 3

CIN 1

ASC-US

Atypical Glandular Cells of Uncertain Significance

AGUS

Cervical Cancer

Treatments

Other: Liquid-based cytology

Diagnostic Test: Colposcopy

Other: Molecular screening

Procedure: Physical examination

Diagnostic Test: Histopathology

Other: HPV DNA test

Study type

Interventional

Funder types

Industry

Identifiers

NCT07211204

PROT-ATSO-INV-003

2024-EXT-886 (Other Identifier)

Details and patient eligibility

About

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

Full description

The primary goal of this study is to compare the efficacy of the 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:

Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.
Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.
Venipuncture to obtain a blood sample.
Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.
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 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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 (less than 10 mL for the blood sample).

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

Screening for reactive cellular changes in the cervix

Other group

Description:

Participants will be drawn from an open population, so they will be asymptomatic for any cervical disease. Based on colposcopy, there will be four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesion (LSIL, CIN-1), high-grade squamous intraepithelial lesion (HSIL, CIN-2/3), and cervical cancer (CC).

Treatment: