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
Lead Sponsor
Timser SAPI de CV
Enrollment
0
Start Date
2026-02-27
Completion Date
2026-02-27
Study Type
INTERVENTIONAL
Official Title
Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population
Age Range
18 Years – 85 Years
Sex
FEMALE
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).
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.
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
The number of years since menarche to sexual debut will be calculated as follows: NYSMSD = Age of Sexual Debut - Age of Menarche
Time frame: During the first visit (Day 1) by clinical interview.
Number of lifetime sexual partners
The number of lifetime sexual partners of the participants will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
Number of years since last cytology
The year of last or previous cytology will be obtained during the clinical interview. The number of years since las cytology will be calculated as follows: NYSLCy =Year of Participation in the Study - Year of Last/Previous Cytology.
Time frame: During the first visit (Day 1) by clinical interview.
Number of years since colposcopy
The year of last or previous colposcopy will be obtained during the clinical interview. The number of years since last colposcopy will be calculated as follows: NYSLCo =Year of Participation in the Study - Year of Last/Previous Colposcopy.
Time frame: During the first visit (Day 1) by clinical interview.
Number of abortions
The number of abortions will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
Number of vaginal deliveries
The number of vaginal deliveries will be obtained during the clinical interview
Time frame: During the first visit (Day 1) by clinical interview.
Number of Caesarean sections
The number of Caesarean sections will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
Number of cigarettes per week
The number of cigarettes per week will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
Clinica Reina Madre Metepec, San Mateo Atenco, Mexico