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NCT Number: NCT07480902

Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer

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

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Key information

Conditions

I) Atypical Squamous Cells of Undetermined Significance (ASC-US) Atypical Squamous Cells of the Cervix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female 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) Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Precancerous Conditions Squamous Intraepithelial Lesions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms V) High-grade Squamous Intraepithelial Lesion (HSIL) VI) Cervical Cancer

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Consultorio Médico TIMSER

Mexico City, 14210, Mexico

Location status: Recruiting

About this study

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:

  • 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Examination

Procedure

Physical examination and interview for obtaining a medical record of each participant

Liquid-based cytology

Other

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

Molecular screening

Other

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 test

Other

HPV DNA detection is performed using a cervical swab

Colposcopy

Diagnostic Test

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

Histopathology

Diagnostic 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

Primary outcomes

  1. Liquid-based Cytology results (categorical)

    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.

    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.

  2. Molecular screening result (numeric)

    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

    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.

  3. HPV test results (categorical)

    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.

    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.

  4. Colposcopy diagnosis (categorical)

    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.

    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.

  5. Histopathology diagnosis (cathegorical)

    Time frame: 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.

    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.

Secondary outcomes

  1. Age (numeric)

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

    The study physician will record the participants date of birth. Age (in years) will be calculated in reference to the first visit date.

  2. Body Mass Index BMI (numeric)

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

    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.

  3. Blood pressure (numeric)

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

    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.

  4. Ethnicity (categorical)

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

    Ethnicity data will be obtained through clinical interview. Ethnicity is linked to cultural expression and identity.

    Ethnicity options:

    Hispanic/Latino. Not Hispanic/Latino.

  5. Race (categorical)

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

    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.

  6. Age at Menarche (numeric)

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

    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.

  7. Age at sexual debut (numeric)

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

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

  8. Number of years since menarche to sexual debut (numeric)

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

    The number of years since menarche to sexual debut will be calculated as follows:

    NYSMSD = Age of Sexual Debut - Age of Menarche.

  9. Number of lifetime sexual partners (numeric)

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

    The number of lifetime sexual partners of the participants will be obtained during the clinical interview.

  10. Number of years since last cytology (numeric)

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

    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.

  11. Number of years since colposcopy (numeric)

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

    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.

  12. Number of abortions (numeric)

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

    The number of abortions will be obtained during the clinical interview.

  13. Number of vaginal deliveries (numeric)

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

    The number of vaginal deliveries will be obtained during the clinical interview.

  14. Number of Caesarean sections (numeric)

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

    The number of Caesarean sections will be obtained during the clinical interview.

  15. Number of cigarettes per week (numeric)

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

    The number of cigarettes per week will be obtained during the clinical interview.

Other outcomes

  1. p16 immunohistochemistry results (dichotomic)

    Time frame: 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.

    This test detects the human biomarker p16INK4a widely used for assessing HPV infection in a cervical biopsy.

    P16 IHC results:

    Positive. Negative. Inconclusive.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Timser SAPI de CV

Industry

Registry information

Official study title

Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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