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

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

Study Overview

• Status: Recruiting
• 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-3; IV) Low-grade Squamous Intraepithelial Lesion (LSIL); V) High-grade Squamous Intraepithelial Lesion (HSIL); VI) Cervical Cancer
• Intervention / Treatment: Procedure: Physical examination; Other: Liquid-based cytology; Other: Molecular screening; Other: HPV DNA test; Diagnostic test: Colposcopy; Diagnostic test: Histopathology

Detailed Description

The primary goal of this study is to compare the efficacy of liquid-based 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 liquid-based 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
• Enrollment (Estimated): 558
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mercedes Gutiérrez-Smith, Bachelor of Arts in History; Phone Number: +52-55-9057-1000; Email: mercedes@atsopharma.com
• Study Contact Backup: Name: Fátima R Ruiz-Rosales, Bachelor of Medicine; Phone Number: +52-56-3953-3339; Email: medico@preventix.mx

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14210
      • Recruiting
      • Consultorio Médico TIMSER
      • Principal Investigator: Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol
      • Sub-Investigator: Víctor M Vargas-Aguilar, MD in OB/GY & Gynecol Oncol
      • Contact: Fátima R Ruiz-Rosales, Bachelor of Medicine; Phone Number: +52-56-3953-3339; Email: medico@preventix.mx
      • Contact: Violeta G Jardines-Pérez; Phone Number: +52-56-3230-7157; Email: violeta.jardines@preventix.mx
      • Sub-Investigator: Fátima R Ruiz-Rosales, Bachelor of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 for testing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Screening for reactive cellular changes in the cervix; 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)	Procedure: Physical examination; Physical examination and interview for obtaining a medical record of each participant; 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
Other: Cervical biopsy; Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
Liquid-based Cytology results (categorical)	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.	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 result (numeric)	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 will be calculated using a ROC curve with the gold standard.	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 on the sample. Negative HPV test: Only if none of the fifteen genotypes are detected on the sample.	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.
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.	The biopsy for histopathology will be drawn during the first visit (Day 1). Histopathology is the gold standard for cervical cancer diagnosis. Biopsies will be drawn only from women with positive colposcopy results.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age (numeric)	The study physician will record the participants date of birth. Age (in years) will be calculated in reference to the first visit date.	During the first visit (Day 1).
Body Mass Index BMI (numeric)	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.	During the first visit (Day 1).
Blood pressure (numeric)	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, e.g., 120 mmHg. Diastolic pressure, e.g., 80 mmHg. The final result will display the two independent measurements, e.g., 120/80 mmHg.	During the first visit (Day 1).
Ethnicity (categorical)	Ethnicity data will be obtained through clinical interview. Ethnicity is linked to cultural expression and identity. Ethnicity options: Hispanic/Latino. Not Hispanic/Latino.	During the first visit (Day 1) by clinical interview.
Race (categorical)	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.	During the first visit (Day 1) by clinical interview.
Age at Menarche (numeric)	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.	During the first visit (Day 1) by clinical interview.
Age at sexual debut (numeric)	The age at sexual debut -in years- will be obtained during the clinical interview. The age will be recorded in years.	During the first visit (Day 1) by clinical interview.
Number of years since menarche to sexual debut (numeric)	The number of years since menarche to sexual debut will be calculated as follows: NYSMSD = Age of Sexual Debut - Age of Menarche.	During the first visit (Day 1) by clinical interview.
Number of lifetime sexual partners (numeric)	The number of lifetime sexual partners of the participants will be obtained during the clinical interview.	During the first visit (Day 1) by clinical interview.
Number of years since last cytology (numeric)	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.	During the first visit (Day 1) by clinical interview.
Number of years since colposcopy (numeric)	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.	During the first visit (Day 1) by clinical interview.
Number of abortions (numeric)	The number of abortions will be obtained during the clinical interview.	During the first visit (Day 1) by clinical interview.
Number of vaginal deliveries (numeric)	The number of vaginal deliveries will be obtained during the clinical interview.	During the first visit (Day 1) by clinical interview.
Number of Caesarean sections (numeric)	The number of Caesarean sections will be obtained during the clinical interview.	During the first visit (Day 1) by clinical interview.
Number of cigarettes per week (numeric)	The number of cigarettes per week will be obtained during the clinical interview.	During the first visit (Day 1) by clinical interview.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
p16 immunohistochemistry results (dichotomic)	This test detects the human biomarker p16INK4a widely used for assessing HPV infection in a cervical biopsy. P16 IHC results: Positive. Negative. Inconclusive.	This test will be performed using the remaining tissue from randomly selected biopsies. None of the participants will be biopsied more than once. Biopsies will be drawn during the first visit (Day 1) only if a lesion/malignancy is detected in colposcopy.

Collaborators and Investigators

• Sponsor: Timser SAPI de CV
• Investigators: Principal Investigator: Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol, Consultorio Médico TIMSER

Publications and helpful links

General Publications

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• Reyes-Hernández, D. O. et al. Novel Serum Protein Biomarkers for Precancerous Cervical Lesions and Cervical Cancer. Glob J Health Sci 16, 44 (2024).
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• William, W., Ware, A., Basaza-Ejiri, A. H. & Obungoloch, J. Cervical cancer classification from Pap-smears using an enhanced fuzzy C-means algorithm. Inform Med Unlocked 14, 23-33 (2019).
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• Giannella, L. et al. HPV-Negative Adenocarcinomas of the Uterine Cervix: From Molecular Characterization to Clinical Implications. Int J Mol Sci 23, (2022).
• Jenkins, D. et al. Molecular and pathological basis of HPV-negative cervical adenocarcinoma seen in a global study. Int J Cancer 147, 2526-2536 (2020).
• Lee, J. E., Chung, Y., Rhee, S. & Kim, T. H. Untold story of human cervical cancers: HPV-negative cervical cancer. BMB Rep 55, 429-438 (2022).
• Mexican Social Security Institute (IMSS) & Government of Mexico. Clinical Practice Guideline. Prevention and early detection of cervical cancer. At the primary care level. https://www.imss.gob.mx/sites/all/statics/guiasclinicas/146GER.pdf (2011).
• World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention. (World Health Organization, Geneva, 2021).
• Sadat Najib, F. et al. Diagnostic Accuracy of Cervical Pap Smear and Colposcopy in Detecting Premalignant and Malignant Lesions of Cervix. Indian J Surg Oncol 11, 453-458 (2020).
• Mayrand, M.-H. et al. Human Papillomavirus DNA versus Papanicolaou Screening Tests for Cervical Cancer. New England Journal of Medicine 357, 1579-1588 (2007).
• Kitchener, H. C., Castle, P. E. & Cox, J. T. Chapter 7: Achievements and limitations of cervical cytology screening. Vaccine 24, S3/63-S3/70 (2006).
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• Bravington, A. et al. Challenges and opportunities for cervical screening in women over the age of 50 years: a qualitative study. British Journal of General Practice 72, E873-E881 (2022).
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• Collins, S., Rollason, T. P., Young, L. S. & Woodman, C. B. J. Cigarette smoking is an independent risk factor for cervical intraepithelial neoplasia in young women: A longitudinal study. Eur J Cancer 46, 405-411 (2010).
• Tekalegn, Y. et al. High parity is associated with increased risk of cervical cancer: Systematic review and meta-analysis of case-control studies. Women's Health 18, (2022).
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• World Health Organization & International Agency for Research on Cancer. Global Cancer Observatory. https://gco.iarc.fr/today/home

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: LSIL; Cervical cancer; CIN; HSIL; Cervical precursor lesions; Reactive cellular changes
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Neoplasms; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix; Squamous Intraepithelial Lesions; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Behavior Control; Immobilization; Urogenital Surgical Procedures; Genetic Techniques; Gynecologic Surgical Procedures; Obstetric Surgical Procedures; Diagnostic Techniques, Obstetrical and Gynecological; Molecular Diagnostic Techniques; Restraint, Physical; Colposcopy; Human Papillomavirus DNA Tests
• Other Study ID Numbers: PROT-ATSO-INV-011; 1090 (Ethics Committee of iPharma SA de CV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All de-identified individual participant data will be publicly available in the supplementary material associated with the scientific publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No