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

NCT07211204 | Withdrawn DMC

• 2 other identifiers: PROT-ATSO-INV-0032024-EXT-886
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atypical Squamous Cell of Undetermined Significance; Atypical Glandular Cells of Uncertain Significance; AGUS; Cervical Intraepithelial Neoplasia (CIN); CIN 1; CIN 2; CIN 3; Cervical Cancer; ASC-US

Keywords

Cervical precursor lesions; Reactive cellular changes; Cervical cancer

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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 (14)

• Body Mass Index (BMI)

  During the first visit (Day 1).

• Blood pressure

  During the first visit (Day 1).

• Ethnicity

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

• Race

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

• Age at Menarche

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

Other Outcomes (1)

• p16 immunohistochemistry results (dichotomic)

  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.

Study Arms (2)

Screening for reactive cellular changes in the cervix

OTHER

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; Other: Liquid-based cytology; Other: Molecular screening; Other: HPV DNA test; Diagnostic Test: Colposcopy

Histopathology of cervical biopsy

OTHER

Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied.

Diagnostic Test: Histopathology

Interventions

Physical examination PROCEDURE

Physical examination and interview for obtaining a medical record

Also known as: Clinical examination

Screening for reactive cellular changes in the cervix

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.

Also known as: LBC

Screening for reactive cellular changes in the cervix

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.

Also known as: Circulating biomarker screening

Screening for reactive cellular changes in the cervix

HPV DNA test OTHER

HPV DNA detection is performed using a cervical swab.

Also known as: HPV PCR test, HPV screening, HPV detection, Human papillomavirus DNA test

Screening for reactive cellular changes in the cervix

Colposcopy DIAGNOSTIC_TEST

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

Screening for reactive cellular changes in the cervix

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.

Also known as: Cervical biopsy, Biopsy, Histopathologic examination, Histopathologic analysis, Hematoxylin and eosin stain (H&E) in histopathology

Histopathology of cervical biopsy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Timser SAPI de CV: lead

Study Sites (1)

Clinica Reina Madre Metepec

San Mateo Atenco, State of Mexico, 52105, Mexico

Location

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  BACKGROUND

Related Links

• World Health Organization \& International Agency for Research on Cancer. Global Cancer Observatory
• World Health Organization. Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem
• Sellors JW \& Sankaranarayanan R. An introduction to Cervical Intraepithelial Neoplasia (CIN). in Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners manual
• International Agency for Research on Cancer. CanScreen5. Cervical Cancer Screening Programme. Country Fact Sheet: Mexico
• Mexico's Ministry of Health. NOM-014-SSA2-1994. For Prevention, Detection, Diagnosis, Treatment, Control and Epidemiological Surveillance of Cervical Cancer
• World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention.
• Mexican Social Security Institute (IMSS) \& Mexican Government. Clinical Practice Guidelines. Prevention and Timely Detection of Cervical Cancer at the First-Level of Care
• William, W., Ware, A., Basaza-Ejiri, A. H. \& Obungoloch, J. Automated diagnosis and classification of cervical cancer from Pap-smear images. in 2019 IST-Africa Week Conference, IST-Africa 2019
• Reyes-Hernández, D. O. et al. Novel Serum Protein Biomarkers for Precancerous Cervical Lesions and Cervical Cancer. Glob J Health Sci 16, 44 (2024).
• Mexican Social Security Institute (IMSS) \& Mexican Government. Clinical Practice Guidelines. Treatment of Cervical Cancer at the Second and Third-Level of Care

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Restraint, Physical; Human Papillomavirus DNA Tests; Colposcopy; Biopsy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Molecular Diagnostic Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Techniques; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Cytodiagnosis; Cytological Techniques; Specimen Handling

Study Officials

• Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol

  Clinica Reina Madre Metepec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Given this is a screening study: I) Participant. All enrolled participants will be asymptomatic women. Group assignment will be defined after colposcopy or histopathology (when applicable). II) Care Provider. The gynecologist will not have a priori knowledge of the condition of the participant. During colposcopy only those participants with abnormal results will be biopsied. III) Investigator. None of the investigators performing the tests (cytology, HPV detection, molecular screening, or histopathology) will know each other's results.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group 1. All participants will receive a colposcopy, Pap smear, and a venipuncture. Diagnosis by colposcopy will set four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesions LSIL (CIN-1), high-grade squamous intraepithelial lesions HSIL (CIN-2/3), and cervical cancer (CC). Group 2. The participants in groups LSIL, HSIL, and CC will be biopsied. The histopathology analysis of the biopsy is the gold standard for the diagnosis.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: October 7, 2025
• Study Start: February 27, 2026
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)