Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT07211204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065309', 'term': 'Atypical Squamous Cells of the Cervix'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}, {'id': 'D061809', 'term': 'Human Papillomavirus DNA Tests'}, {'id': 'D003127', 'term': 'Colposcopy'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "Given this is a screening study:\n\nI) Participant. All enrolled participants will be asymptomatic women. Group assignment will be defined after colposcopy or histopathology (when applicable).\n\nII) 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.\n\nIII) Investigator. None of the investigators performing the tests (cytology, HPV detection, molecular screening, or histopathology) will know each other's results."}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).\n\nGroup 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'p16 immunohistochemistry results (dichotomic)', 'timeFrame': '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.', 'description': 'This test detects the human biomarker p16INK4a widely used for assessing HPV infection in a cervical biopsy.\n\nP16 IHC results:\n\nPositive. Negative. Inconclusive.'}], 'primaryOutcomes': [{'measure': 'Liquid-based Cytology LBC results (categorical)', 'timeFrame': '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.', 'description': "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.\n\nCytology's results:\n\nNegative 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."}, {'measure': 'Molecular screening results (dichotomic)', 'timeFrame': '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.', 'description': '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:\n\nNegative. Only if the three independent biomarkers are below their cutoff values.\n\nPositive. If any of the three independent biomarkers is equal to or greater than its cutoff value.\n\nCutoff values are as follows:\n\nBiomarker 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.'}, {'measure': 'HPV test results (categorical)', 'timeFrame': '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.', 'description': 'HPV test will detect fifteen different high-risk genotypes by PCR:\n\nHPV-16 genotype. HPV-18 genotype. HPV-pool (including HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, and 68 genotypes).\n\nThe final test result will be assigned as follows:\n\nPositive HPV test: If at least one of the fifteen genotypes is detected. Negative HPV test: Only if none of the fifteen genotypes are detected.'}, {'measure': 'Colposcopy diagnosis (categorical)', 'timeFrame': '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.', 'description': '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.\n\nColposcopy results:\n\nNegative 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.\n\nNegative 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.'}, {'measure': 'Histopathology diagnosis (cathegorical)', 'timeFrame': '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.', 'description': '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).\n\nHistopathology results:\n\nNegative 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.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'During the first visit (Day 1).', 'description': 'The study physician will record the participants:\n\nWeight in kilograms (kg). Height in meters (m). The Body Mass Index will be calculated as follows: BMI = kg/m\\^2.'}, {'measure': 'Blood pressure', 'timeFrame': 'During the first visit (Day 1).', 'description': 'Blood pressure is the amount of force the blood uses to get through the circulatory system measured in mmHg. It consists of two measurements:\n\nSystolic pressure in mmHg, e.g., 120 mmHg. Diastolic pressure in mmHg, e.g., 80 mmHg. The final result will display the two independent measurements, e.g., 120/80 mmHg.'}, {'measure': 'Ethnicity', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'Ethnicity data will be obtained through clinical interview. Ethnicity is linked to cultural expression and identity.\n\nEthnicity options:\n\nHispanic/Latino. Not Hispanic/Latino.'}, {'measure': 'Race', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'Race data will be obtained through clinical interview. Race is linked to physical characteristics.\n\nRace options:\n\nAmerican Indian. Alaska Native. Asian. Black or African American. African Mexican. Native Hawaiian or Other Pacific Islander. Mexican Original People. White.'}, {'measure': 'Age at Menarche', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': '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.'}, {'measure': 'Age at sexual debut', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The age at sexual debut -in years- will be obtained during the clinical interview. The age will be recorded in years.'}, {'measure': 'Number of years since menarche to sexual debut', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The number of years since menarche to sexual debut will be calculated as follows:\n\nNYSMSD = Age of Sexual Debut - Age of Menarche'}, {'measure': 'Number of lifetime sexual partners', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The number of lifetime sexual partners of the participants will be obtained during the clinical interview.'}, {'measure': 'Number of years since last cytology', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': '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:\n\nNYSLCy =Year of Participation in the Study - Year of Last/Previous Cytology.'}, {'measure': 'Number of years since colposcopy', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': '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:\n\nNYSLCo =Year of Participation in the Study - Year of Last/Previous Colposcopy.'}, {'measure': 'Number of abortions', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The number of abortions will be obtained during the clinical interview.'}, {'measure': 'Number of vaginal deliveries', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The number of vaginal deliveries will be obtained during the clinical interview'}, {'measure': 'Number of Caesarean sections', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The number of Caesarean sections will be obtained during the clinical interview.'}, {'measure': 'Number of cigarettes per week', 'timeFrame': 'During the first visit (Day 1) by clinical interview.', 'description': 'The number of cigarettes per week will be obtained during the clinical interview.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical precursor lesions', 'Reactive cellular changes', 'Cervical cancer'], 'conditions': ['Atypical Squamous Cell of Undetermined Significance', 'ASC-US', 'Atypical Glandular Cells of Uncertain Significance', 'AGUS', 'Cervical Intraepithelial Neoplasia (CIN)', 'CIN 1', 'CIN 2', 'CIN 3', 'Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '33380887', 'type': 'BACKGROUND', 'citation': 'Serdar CC, Cihan M, Yucel D, Serdar MA. 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Risk Factors Associated with Invasive Cervical Carcinoma among Women Attending Jimma University Specialized Hospital, Southwest Ethiopia: A Case Control Study. Ethiop J Health Sci. 2015 Oct;25(4):345-52. doi: 10.4314/ejhs.v25i4.8.'}, {'pmid': '25302174', 'type': 'BACKGROUND', 'citation': 'McGraw SL, Ferrante JM. Update on prevention and screening of cervical cancer. World J Clin Oncol. 2014 Oct 10;5(4):744-52. doi: 10.5306/wjco.v5.i4.744.'}, {'pmid': '19167657', 'type': 'BACKGROUND', 'citation': 'Hwang LY, Ma Y, Benningfield SM, Clayton L, Hanson EN, Jay J, Jonte J, Godwin de Medina C, Moscicki AB. Factors that influence the rate of epithelial maturation in the cervix in healthy young women. J Adolesc Health. 2009 Feb;44(2):103-110. doi: 10.1016/j.jadohealth.2008.10.006.'}, {'pmid': '23066159', 'type': 'BACKGROUND', 'citation': 'Ruiz AM, Ruiz JE, Gavilanes AV, Eriksson T, Lehtinen M, Perez G, Sings HL, James MK, Haupt RM; FUTURE I and II Study Group. Proximity of first sexual intercourse to menarche and risk of high-grade cervical disease. J Infect Dis. 2012 Dec 15;206(12):1887-96. doi: 10.1093/infdis/jis612. Epub 2012 Oct 12.'}, {'type': 'BACKGROUND', 'citation': 'Mok, S. C., Wong, K. K., Lu, K. H., Munger, K. & Nagymanyoki, Z. Molecular basis of gynecologic diseases. in Essential Concepts in Molecular Pathology 409-424 (Elsevier, 2020). doi:10.1016/B978-0-12-813257-9.00023-1.'}], 'seeAlsoLinks': [{'url': 'https://gco.iarc.fr/today/home', 'label': 'World Health Organization \\& International Agency for Research on Cancer. Global Cancer Observatory'}, {'url': 'https://www.who.int/publications/i/item/9789240014107', 'label': 'World Health Organization. Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem'}, {'url': 'https://screening.iarc.fr/colpo.php', 'label': 'Sellors JW \\& Sankaranarayanan R. An introduction to Cervical Intraepithelial Neoplasia (CIN). in Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners manual'}, {'url': 'https://canscreen5.iarc.fr/?page=countryfactsheetcervix&q=MEX&rc=', 'label': 'International Agency for Research on Cancer. CanScreen5. Cervical Cancer Screening Programme. Country Fact Sheet: Mexico'}, {'url': 'https://www.gob.mx/cms/uploads/attachment/file/10397/NOM-014-SSA2-1994.pdf', 'label': "Mexico's Ministry of Health. NOM-014-SSA2-1994. For Prevention, Detection, Diagnosis, Treatment, Control and Epidemiological Surveillance of Cervical Cancer"}, {'url': 'https://www.who.int/publications/i/item/9789240030824', 'label': 'World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention.'}, {'url': 'https://www.imss.gob.mx/sites/all/statics/guiasclinicas/146GER.pdf', 'label': 'Mexican Social Security Institute (IMSS) \\& Mexican Government. Clinical Practice Guidelines. Prevention and Timely Detection of Cervical Cancer at the First-Level of Care'}, {'url': 'https://ieeexplore.ieee.org/document/8764887', 'label': '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'}, {'url': 'https://ccsenet.org/journal/index.php/gjhs/article/view/0/50473', 'label': 'Reyes-Hernández, D. O. et al. Novel Serum Protein Biomarkers for Precancerous Cervical Lesions and Cervical Cancer. Glob J Health Sci 16, 44 (2024).'}, {'url': 'https://www.imss.gob.mx/sites/all/statics/guiasclinicas/333GER.pdf', 'label': 'Mexican Social Security Institute (IMSS) \\& Mexican Government. Clinical Practice Guidelines. Treatment of Cervical Cancer at the Second and Third-Level of Care'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "The primary goal of this study is to compare the efficacy of the 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:\n\n1. Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.\n2. Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.\n3. Venipuncture to obtain a blood sample.\n4. Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.\n5. Biopsy, only if the gynecologist detects a cervical lesion or another abnormality during colposcopy.\n\nThe gynecologist will make preliminary recommendations based on the colposcopic findings.\n\nDuring the second visit the study's gynecologist will explain the tests' results and provide clinical recommendations to each participant.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be in good general health.\n* Age 18-85 years.\n* A minimum fast of 6 hours and no more than 12 hours.\n* Refrain from sexual intercourse 24 hours before the study.\n* Give written informed consent.\n\nExclusion Criteria:\n\n* Having a subtotal, total, or radical hysterectomy.\n* 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.\n* Being under oncological treatment (chemotherapy, radiotherapy and/or brachytherapy).\n* Being on their period.\n* Have a previous confirmatory diagnosis of HIV and/or hepatitis infection.\n* Having taken antiplatelet medications, e.g., acetylsalicylic acid, at least 24 hours before the study.\n\nDiscontinuation Criteria:\n\n* If the participant refuses any of the study procedures.\n* If the study gynecologist detects that the participant has had a hysterectomy.\n* If the volume of the biological samples is insufficient (less than 10 mL for the blood sample).'}, 'identificationModule': {'nctId': 'NCT07211204', 'briefTitle': 'Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Timser SAPI de CV'}, 'officialTitle': 'Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population', 'orgStudyIdInfo': {'id': 'PROT-ATSO-INV-003'}, 'secondaryIdInfos': [{'id': '2024-EXT-886', 'type': 'OTHER', 'domain': 'Ethics Committee of Medica Sur'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Screening for reactive cellular changes in the cervix', 'description': '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).', 'interventionNames': ['Procedure: Physical examination', 'Other: Liquid-based cytology', 'Other: Molecular screening', 'Other: HPV DNA test', 'Diagnostic Test: Colposcopy']}, {'type': 'OTHER', 'label': 'Histopathology of cervical biopsy', 'description': 'Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied.', 'interventionNames': ['Diagnostic Test: Histopathology']}], 'interventions': [{'name': 'Physical examination', 'type': 'PROCEDURE', 'otherNames': ['Clinical examination'], 'description': 'Physical examination and interview for obtaining a medical record', 'armGroupLabels': ['Screening for reactive cellular changes in the cervix']}, {'name': 'Liquid-based cytology', 'type': 'OTHER', 'otherNames': ['LBC'], 'description': 'Screening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope.', 'armGroupLabels': ['Screening for reactive cellular changes in the cervix']}, {'name': 'Molecular screening', 'type': 'OTHER', 'otherNames': ['Circulating biomarker screening'], 'description': '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.', 'armGroupLabels': ['Screening for reactive cellular changes in the cervix']}, {'name': 'HPV DNA test', 'type': 'OTHER', 'otherNames': ['HPV PCR test', 'HPV screening', 'HPV detection', 'Human papillomavirus DNA test'], 'description': 'HPV DNA detection is performed using a cervical swab.', 'armGroupLabels': ['Screening for reactive cellular changes in the cervix']}, {'name': 'Colposcopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope.', 'armGroupLabels': ['Screening for reactive cellular changes in the cervix']}, {'name': 'Histopathology', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Cervical biopsy', 'Biopsy', 'Histopathologic examination', 'Histopathologic analysis', 'Hematoxylin and eosin stain (H&E) in histopathology'], 'description': '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.', 'armGroupLabels': ['Histopathology of cervical biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52105', 'city': 'San Mateo Atenco', 'state': 'State of Mexico', 'country': 'Mexico', 'contacts': [{'name': 'Mariana Ramírez, Bachelor of Social Work', 'role': 'CONTACT', 'email': 'mariana.ramirez@reinamadre.mx', 'phone': '+52-55-3479-4936'}, {'name': 'Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Víctor M Vargas-Aguilar, MD in OB/GY & Gynecol Oncol', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinica Reina Madre Metepec', 'geoPoint': {'lat': 19.26757, 'lon': -99.53214}}], 'centralContacts': [{'name': 'Mercedes Gutiérrez-Smith, Bachelor of Arts in History', 'role': 'CONTACT', 'email': 'mercedes@atsopharma.com', 'phone': '+52-55-9057-1000'}, {'name': 'Alba E Hernández-Sánchez, Bachelor in Computer Science', 'role': 'CONTACT', 'email': 'albah@atsopharma.com', 'phone': '+52-56-3230-7157'}], 'overallOfficials': [{'name': 'Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Reina Madre Metepec'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All de-identified individual participant data will be publicly available in the supplementary material associated with the scientific publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Timser SAPI de CV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}