I) Atypical Squamous Cells of Undetermined Significance (ASC-US)NCT07480902

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

A study testing Physical examination, Liquid-based cytology and Molecular screening in people with I) Atypical Squamous Cells of Undetermined Significance (ASC-US) and II) Atypical Glandular Cells of Uncertain Significance (AGUS), run by Timser SAPI de CV at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for: 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
What is being tested?: Physical examination, Liquid-based cytology and Molecular screening
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 558 participants
Where: 1 siteMexico
Study dates: 3 Feb 2026to Jun 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mercedes Gutiérrez-Smith, Bachelor of Arts in History contact

+52-55-9057-1000

mercedes@atsopharma.com

Fátima R Ruiz-Rosales, Bachelor of Medicine contact

+52-56-3953-3339

medico@preventix.mx

Mexico1 site, 1 recruiting

Consultorio Médico TIMSER
Mexico City, Mexico City, 14210
Fátima R Ruiz-Rosales, Bachelor of Medicine, +52-56-3953-3339, medico@preventix.mx
Violeta G Jardines-Pérez, +52-56-3230-7157, violeta.jardines@preventix.mx
Recruiting

Other trials in Mexico

About this study

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

Read the 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:

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.

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
Being tested: Physical examination, Liquid-based cytology, Molecular screening, HPV DNA test, Colposcopy
Keywords: Cervical precursor lesions, LSIL, HSIL, CIN, Reactive cellular changes, Cervical cancer
Medical subject headings: Atypical Squamous Cells of the Cervix, Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical examinationProcedure or surgery
Physical examination and interview for obtaining a medical record of each participant
Liquid-based cytologyOther
Screening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope
Molecular screeningOther
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 testOther
HPV DNA detection is performed using a cervical swab
ColposcopyDiagnostic test
A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope
HistopathologyDiagnostic 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

Study groups in NCT07480902
Study group	Role	What they receive
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) Receives: Procedure: Physical examination; Other: Liquid-based cytology; Other: Molecular screening; Other: HPV DNA test; Diagnostic Test: Colposcopy
Cervical biopsy	Other	Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied Receives: Diagnostic Test: Histopathology

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (15)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the first visit (Day 1) by clinical interview.
Number of abortions (numeric)
The number of abortions will be obtained during the clinical interview.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the first visit (Day 1) by clinical interview.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 2026Jun 2026

First posted18 Mar 2026
Study start3 Feb 2026
Primary completionApr 2026 (estimated)
Study completionJun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (52)Papers the sponsor has linked to this study.
Other trials for I) Atypical Squamous Cells of Undetermined Significance (ASC-US)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 558 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07480902
Sponsor's protocol ID: PROT-ATSO-INV-011
Other IDs: 1090
Status last verified: Mar 2026
First submitted: 13 Mar 2026
Last updated: 18 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: All de-identified individual participant data will be publicly available in the supplementary material associated with the scientific publication.

Publications

Mayorga-Bautista, C. D. et al. Prevalence of high-grade intraepithelial lesions in women aged 15-25 years with cytology report of human papillomavirus infection. Ginecol Obstet Mex 89, (2021).
Seefoo-Jarquin P, Sosa-Jurado F, Maycotte-Gonzalez P. [Epidemiological Panorama of Cervical Dysplasia in a First-Level Care Unit]. Rev Med Inst Mex Seguro Soc. 2023 Mar 1;61(2):155-162. Spanish.
PubMed 37201194
Araujo, I., Rosales, B., Peña, I. & Araujo Grijalva, I. Sensitivity and Specificity of Cervicouterine Cytology and the PCR-hrHPV test with Histopathological diagnosis, at the "Solon Espinosa Ayala" Hospital, Solca-Quito. Oncología (Ecuador) (2017) doi:10.33821/227.
DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
PubMed 3203132
Mexican Social Security Institute (IMSS) & Government of Mexico. Clinical Practice Guideline. Treatment of Cervical Cancer at the Second and Third Levels of Care. https://www.imss.gob.mx/sites/all/statics/guiasclinicas/333GER.pdf (2017).
Hu ZY, Xiao L, Bode AM, Dong Z, Cao Y. Glycolytic genes in cancer cells are more than glucose metabolic regulators. J Mol Med (Berl). 2014 Aug;92(8):837-45. doi: 10.1007/s00109-014-1174-x. Epub 2014 Jun 8.
PubMed 24906457
Xue C, Gu X, Li G, Bao Z, Li L. Expression and Functional Roles of Eukaryotic Initiation Factor 4A Family Proteins in Human Cancers. Front Cell Dev Biol. 2021 Nov 19;9:711965. doi: 10.3389/fcell.2021.711965. eCollection 2021.
PubMed 34869305
Li H, Liu J, Shen S, Dai D, Cheng S, Dong X, Sun L, Guo X. Pan-cancer analysis of alternative splicing regulator heterogeneous nuclear ribonucleoproteins (hnRNPs) family and their prognostic potential. J Cell Mol Med. 2020 Oct;24(19):11111-11119. doi: 10.1111/jcmm.15558. Epub 2020 Sep 11.
PubMed 32915499
Dreyfuss G, Matunis MJ, Pinol-Roma S, Burd CG. hnRNP proteins and the biogenesis of mRNA. Annu Rev Biochem. 1993;62:289-321. doi: 10.1146/annurev.bi.62.070193.001445. No abstract available.
PubMed 8352591
Reyes-Hernández, D. O. et al. Novel Serum Protein Biomarkers for Precancerous Cervical Lesions and Cervical Cancer. Glob J Health Sci 16, 44 (2024).
Checa-Rojas A, Delgadillo-Silva LF, Velasco-Herrera MDC, Andrade-Dominguez A, Gil J, Santillan O, Lozano L, Toledo-Leyva A, Ramirez-Torres A, Talamas-Rohana P, Encarnacion-Guevara S. GSTM3 and GSTP1: novel players driving tumor progression in cervical cancer. Oncotarget. 2018 Apr 24;9(31):21696-21714. doi: 10.18632/oncotarget.24796. eCollection 2018 Apr 24.
PubMed 29774096
World Health Organization & Regional Office for Africa. PapsAI. https://innov.afro.who.int/global-innovation/papsai-3899 (2023).
Global Auto Systems LTD. Paps AI. https://papsai.com/index.html#about (2020).
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 (Institute of Electrical and Electronics Engineers Inc., 2019). doi:10.23919/ISTAFRICA.2019.8764887.
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).