Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population
NCT ID: NCT07211204
Last Updated: 2025-10-07
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-11-30
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
SCREENING
TRIPLE
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.
Study Groups
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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).
Physical examination
Physical examination and interview for obtaining a medical record
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.
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.
HPV DNA test
HPV DNA detection is performed using a cervical swab.
Colposcopy
A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope.
Histopathology of cervical biopsy
Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied.
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.
Interventions
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Physical examination
Physical examination and interview for obtaining a medical record
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.
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.
HPV DNA test
HPV DNA detection is performed using a cervical swab.
Colposcopy
A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
85 Years
FEMALE
Yes
Sponsors
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Timser SAPI de CV
INDUSTRY
Responsible Party
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Principal Investigators
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Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol
Role: PRINCIPAL_INVESTIGATOR
Clinica Reina Madre Metepec
Locations
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Clinica Reina Madre Metepec
San Mateo Atenco, State of Mexico, Mexico
Countries
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Central Contacts
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Mercedes Gutiérrez-Smith, Bachelor of Arts in History
Role: CONTACT
Alba E Hernández-Sánchez, Bachelor in Computer Science
Role: CONTACT
Facility Contacts
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References
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Related Links
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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
Other Identifiers
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2024-EXT-886
Identifier Type: OTHER
Identifier Source: secondary_id
PROT-ATSO-INV-003
Identifier Type: -
Identifier Source: org_study_id
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