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

N/ANot Yet RecruitingNCT07211204

Timser SAPI de CV120 enrolled

Overview

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

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: 1. Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study. 2. Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions. 3. Venipuncture to obtain a blood sample. 4. Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection. 5. 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Enrollment

120

Interventions

Physical examinationPROCEDURE

Physical examination and interview for obtaining a medical record

Liquid-based cytologyOTHER

Screening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope.

Molecular screeningOTHER

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.

HPV DNA testOTHER

HPV DNA detection is performed using a cervical swab.

ColposcopyDIAGNOSTIC_TEST

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

HistopathologyDIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Liquid-based Cytology LBC results (categorical)

Study of cells -of the cervix- using a microscope. Cytology is the official screening test for cervical precursor lesions and/or cervical cancer in most countries. Cytology's results: Negative to lesion/malignancy. Negative with inflammation. Negative with sexually transmitted infection. Negative with HPV/Herpes cytopathic changes. Negative with atrophy. Positive with ASC-US. Positive with ASC-H. Positive with AGUS. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ. Positive with LSIL/HSIL. Positive with adenocarcinoma. Positive with Cancer/Malignancy. Positive with probable lesion/cancer/malignancy.

Time frame: Cervical smear will be taken during the first visit (Day 1). LBC results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.

Molecular screening results (dichotomic)

Molecular screening detects three human protein biomarkers in human sera by Western blot and ELISA. Western blot results are qualitative (band intensity units or IU) and ELISA results are quantitative (ng/mL). The final result for molecular screening test is computed as follows: Negative. Only if the three independent biomarkers are below their cutoff values. Positive. If any of the three independent biomarkers is equal to or greater than its cutoff value. Cutoff values are as follows: Biomarker 1 positive \>= 1.37 IU. Biomarker 1 negative \< 1.37 IU. Biomarker 2 positive \>= 17.74 ng/mL. Biomarker 2 negative \< 17.74 ng/mL. Biomarker 3 positive \>= 0.38 IU. Biomarker 3 negative \< 0.38 IU.

Time frame: Blood samples will be taken during the first visit (Day 1). Molecular screening results will be available within a maximum of 20 days after sampling. All participants will be subjected to this test.

HPV test results (categorical)

HPV test will detect fifteen different high-risk genotypes by PCR: HPV-16 genotype. HPV-18 genotype. HPV-pool (including HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68 genotypes). The final test result will be assigned as follows: Positive HPV test: If at least one of the fifteen genotypes is detected. Negative HPV test: Only if none of the fifteen genotypes are detected.

Time frame: Cervical smear will be taken during the first visit (Day 1). HPV test results will be available within a maximum of 20 days after sampling. This test will be performed by a Licensed Clinical laboratory. All participants will be subjected to this test.

Colposcopy diagnosis (categorical)

Colposcopy is the exploration of the female genitalia -vulva, vagina, and cervix- using a lighted magnifying instrument (colposcope). Its accuracy is higher than that of the cytology. If the gynecologist detects/suspects a lesion or malignancy during colposcopy, a biopsy will be drawn for histopathologic analysis. Colposcopy results: Negative with no alterations. Negative with inflammation. Negative with condyloma/condylomatosis/HPV. Negative with atrophy. Negative with squamous metaplasia. Negative with ectropion/ectopy/cervical erosion/cervical eversion/glandular eversion. Negative with Nabothian cysts. Negative with cervical polyp. Negative with Lichen sclerosus. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ CIN-3. Positive with neoplasia/invasive neoplasia. Positive with LSIL/HSIL. Positive with probable lesion/CIN/LSIL/HSIL.

Time frame: Colposcopy will be performed during the first visit (Day 1). This diagnostic test will be performed by a licensed gynecologist. All participants will be subjected to this diagnostic test. Colposcopy will be used as a reference test.

Histopathology diagnosis (cathegorical)

Histopathology is the microscopic analysis of a stained slide of a cervical biopsy by a licensed pathologist. The standard staining is H\&E (hematoxylin and eosin). Histopathology results: Negative with normal tissue. Negative with cervicitis. Negative with HPV/Herpes infection. Positive with CIN-1. Positive with CIN-2. Positive with CIN-3. Positive with carcinoma in situ CIN-3. Positive LSIL/HSIL. Positive with microinvasive/invasive cancer. Positive with adenocarcinoma. Positive with sarcoma and other tumors. Positive with carcinoma of unknown primary origin/unspecified malignancy.

Time frame: The biopsy for histopathology will be drawn during the first visit (Day 1). Biopsies will be drawn only from women with positive colposcopy results. Histopathology is the gold standard for cervical cancer diagnosis.

Secondary Outcomes

Body Mass Index (BMI)

The study physician will record the participants: Weight in kilograms (kg). Height in meters (m). The Body Mass Index will be calculated as follows: BMI = kg/m\^2.

Time frame: During the first visit (Day 1).

Blood pressure

Blood pressure is the amount of force the blood uses to get through the circulatory system measured in mmHg. It consists of two measurements: Systolic pressure in mmHg, e.g., 120 mmHg. Diastolic pressure in mmHg, e.g., 80 mmHg. The final result will display the two independent measurements, e.g., 120/80 mmHg.

Time frame: During the first visit (Day 1).

Ethnicity

Ethnicity data will be obtained through clinical interview. Ethnicity is linked to cultural expression and identity. Ethnicity options: Hispanic/Latino. Not Hispanic/Latino.

Time frame: During the first visit (Day 1) by clinical interview.

Race

Race data will be obtained through clinical interview. Race is linked to physical characteristics. Race options: American Indian. Alaska Native. Asian. Black or African American. African Mexican. Native Hawaiian or Other Pacific Islander. Mexican Original People. White.

Time frame: During the first visit (Day 1) by clinical interview.

Age at Menarche

Age at menarche -in years- will be obtained during the clinical interview. Menarche is the first menstrual period in a female adolescent, typically occurs between the ages of 10 and 16.

Time frame: During the first visit (Day 1) by clinical interview.

Age at sexual debut

The age at sexual debut -in years- will be obtained during the clinical interview. The age will be recorded in years.

Time frame: During the first visit (Day 1) by clinical interview.

Number of years since menarche to sexual debut

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts