Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07480902
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065309', 'term': 'Atypical Squamous Cells of the Cervix'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'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'}], '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'}]}}, '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': 558}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', '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 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': "Cytology'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 result (numeric)', '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 will be calculated using a ROC curve with the gold standard.'}, {'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 on the sample.\n\nNegative HPV test: Only if none of the fifteen genotypes are detected on the sample.'}, {'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). Histopathology is the gold standard for cervical cancer diagnosis. Biopsies will be drawn only from women with positive colposcopy results.', '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': 'Age (numeric)', 'timeFrame': 'During the first visit (Day 1).', 'description': 'The study physician will record the participants date of birth. Age (in years) will be calculated in reference to the first visit date.'}, {'measure': 'Body Mass Index BMI (numeric)', '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 (numeric)', '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, e.g., 120 mmHg. Diastolic pressure, e.g., 80 mmHg. The final result will display the two independent measurements, e.g., 120/80 mmHg.'}, {'measure': 'Ethnicity (categorical)', '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 (categorical)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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 (numeric)', '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': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical precursor lesions', 'LSIL', 'HSIL', 'CIN', 'Reactive cellular changes', 'Cervical cancer'], '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']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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).'}, {'type': 'BACKGROUND', 'citation': 'Seefoó-Jarquín P, S.-J. F. M.-G. P. Epidemiological overview of cervical dysplasias in a primary care unit. Rev Med Inst Mex Seguro Soc. 61, (2023).'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'DeLong, E. R., DeLong, D. M. & Clarke-Pearson, D. L. Comparing the Areas under Two or More Correlated Receiver Operating Characteristic Curves: A Nonparametric Approach. Biometrics 44, (1988).'}, {'type': 'BACKGROUND', 'citation': '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).'}, {'type': 'BACKGROUND', 'citation': 'Hu, Z. Y., Xiao, L., Bode, A. M., Dong, Z. & Cao, Y. Glycolytic genes in cancer cells are more than glucose metabolic regulators. J Mol Med 92, 837-845 (2014).'}, {'type': 'BACKGROUND', 'citation': '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 9, (2021).'}, {'type': 'BACKGROUND', 'citation': 'Li, H. et al. Pan-cancer analysis of alternative splicing regulator heterogeneous nuclear ribonucleoproteins (hnRNPs) family and their prognostic potential. J Cell Mol Med 24, 11111-11119 (2020).'}, {'type': 'BACKGROUND', 'citation': 'Dreyfuss, G., Matunis, M. J., Piiiol-Roma, S. & Burd, C. G. hnRNP PROTEINS AND THE BIOGENESIS OF mRNA. Annu Rev Biochem 62, 289-321 (1993).'}, {'type': 'BACKGROUND', 'citation': 'Reyes-Hernández, D. O. et al. Novel Serum Protein Biomarkers for Precancerous Cervical Lesions and Cervical Cancer. Glob J Health Sci 16, 44 (2024).'}, {'type': 'BACKGROUND', 'citation': 'Checa-Rojas, A. et al. GSTM3 and GSTP1: novel players driving tumor progression in cervical cancer. Oncotarget 9, 21696-21714 (2018).'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization & Regional Office for Africa. PapsAI. https://innov.afro.who.int/global-innovation/papsai-3899 (2023).'}, {'type': 'BACKGROUND', 'citation': 'Global Auto Systems LTD. Paps AI. https://papsai.com/index.html#about (2020).'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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).'}, {'type': 'BACKGROUND', 'citation': 'William, W., Ware, A., Basaza-Ejiri, A. H. & Obungoloch, J. A Pap-smear analysis tool (PAT) for detection of cervical cancer from pap-smear images. Biomed Eng Online 18, (2019).'}, {'type': 'BACKGROUND', 'citation': 'Shin, M. B. et al. Cost of community-based human papillomavirus self-sampling in Peru: A micro-costing study. The Lancet Regional Health - Americas 8, 100160 (2022).'}, {'type': 'BACKGROUND', 'citation': 'Giannella, L. et al. HPV-Negative Adenocarcinomas of the Uterine Cervix: From Molecular Characterization to Clinical Implications. Int J Mol Sci 23, (2022).'}, {'type': 'BACKGROUND', 'citation': 'Jenkins, D. et al. Molecular and pathological basis of HPV-negative cervical adenocarcinoma seen in a global study. Int J Cancer 147, 2526-2536 (2020).'}, {'type': 'BACKGROUND', 'citation': 'Lee, J. E., Chung, Y., Rhee, S. & Kim, T. H. Untold story of human cervical cancers: HPV-negative cervical cancer. BMB Rep 55, 429-438 (2022).'}, {'type': 'BACKGROUND', 'citation': 'Mexican Social Security Institute (IMSS) & Government of Mexico. Clinical Practice Guideline. Prevention and early detection of cervical cancer. At the primary care level. https://www.imss.gob.mx/sites/all/statics/guiasclinicas/146GER.pdf (2011).'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention. (World Health Organization, Geneva, 2021).'}, {'type': 'BACKGROUND', 'citation': 'Sadat Najib, F. et al. Diagnostic Accuracy of Cervical Pap Smear and Colposcopy in Detecting Premalignant and Malignant Lesions of Cervix. Indian J Surg Oncol 11, 453-458 (2020).'}, {'type': 'BACKGROUND', 'citation': 'Mayrand, M.-H. et al. Human Papillomavirus DNA versus Papanicolaou Screening Tests for Cervical Cancer. New England Journal of Medicine 357, 1579-1588 (2007).'}, {'type': 'BACKGROUND', 'citation': 'Kitchener, H. C., Castle, P. E. & Cox, J. T. Chapter 7: Achievements and limitations of cervical cytology screening. Vaccine 24, S3/63-S3/70 (2006).'}, {'type': 'BACKGROUND', 'citation': 'Coleman, D. Limitations of the cervical smear test as a method of detecting women at risk of cervical cancer. AVMA Medical & Legal Journal 235 The AVMA Medical & Legal Journal 7, (2001).'}, {'type': 'BACKGROUND', 'citation': 'Bravington, A. et al. Challenges and opportunities for cervical screening in women over the age of 50 years: a qualitative study. British Journal of General Practice 72, E873-E881 (2022).'}, {'type': 'BACKGROUND', 'citation': 'Shin, H. Y., Song, S. Y., Jun, J. K., Kim, K. Y. & Kang, P. Barriers and strategies for cervical cancer screening: What do female university students know and want? PLoS One 16, (2021).'}, {'type': 'BACKGROUND', 'citation': 'Petersen, Z. et al. Barriers to uptake of cervical cancer screening services in low-and-middle-income countries: a systematic review. BMC Womens Health 22, (2022).'}, {'type': 'BACKGROUND', 'citation': 'Akinlotan, M. et al. Cervical Cancer Screening Barriers and Risk Factor Knowledge Among Uninsured Women. J Community Health 42, 770-778 (2017).'}, {'type': 'BACKGROUND', 'citation': 'Mexican Ministry of Health. NOM-014-SSA2-1994. For the prevention, detection, diagnosis, treatment, control and epidemiological surveillance of cervical cancer. https://www.gob.mx/cms/uploads/attachment/file/10397/NOM-014-SSA2-1994.pdf (2007).'}, {'type': 'BACKGROUND', 'citation': 'International Agency for Research on Cancer. CanScreen5. Cervical Cancer Screening Programme. Country Fact Sheet: Mexico. https://canscreen5.iarc.fr/?page=countryfactsheetcervix&q=MEX&rc= (2021).'}, {'type': 'BACKGROUND', 'citation': 'Zhang, L. et al. CanScreen5, a global repository for breast, cervical and colorectal cancer screening programs. Nat Med 29, 1135-1145 (2023).'}, {'type': 'BACKGROUND', 'citation': 'Mitra A et al. Cervical intraepithelial neoplasia: screening and management. British Journal of Hospital Medicine 77, C118-C123 (2016).'}, {'type': 'BACKGROUND', 'citation': 'Sellors JW & Sankaranarayanan R. An introduction to Cervical Intraepithelial Neoplasia (CIN). in Colposcopy and treatment of cervical intraepithelial neoplasia: a beginners manual 1-140 (Centro Internacional de Investigaciones sobre el Cáncer (IARC), Lyon, Francia, 2003).'}, {'type': 'BACKGROUND', 'citation': 'Alimena, S., Davis, J., Fichorova, R. N. & Feldman, S. The vaginal microbiome: A complex milieu affecting risk of human papillomavirus persistence and cervical cancer. Curr Probl Cancer 46, (2022).'}, {'type': 'BACKGROUND', 'citation': 'Johnson, C. A., James, D., Marzan, A. & Armaos, M. Cervical Cancer: An Overview of Pathophysiology and Management. Semin Oncol Nurs 35, 166-174 (2019).'}, {'type': 'BACKGROUND', 'citation': 'Ribeiro, A. A. et al. HPV infection and cervical neoplasia: Associated risk factors. Infect Agent Cancer 10, 1-7 (2015).'}, {'type': 'BACKGROUND', 'citation': 'Vesco, K. K. et al. Risk Factors and Other Epidemiologic Considerations for Cervical Cancer Screening: A Narrative Review for the U.S. Preventive Services Task Force. www.annals.org (2011).'}, {'type': 'BACKGROUND', 'citation': 'International Collaboration of Epidemiological Studies of Cervical Cancer. Cervical cancer and hormonal contraceptives: collaborative reanalysis of individual data for 16 573 women with cervical cancer and 35 509 women without cervical cancer from 24 epidemiological studies. The Lancet 370, 1609-1621 (2007).'}, {'type': 'BACKGROUND', 'citation': 'Appleby, P. et al. Cervical carcinoma and sexual behavior: Collaborative reanalysis of individual data on 15,461 women with cervical carcinoma and 29,164 women without cervical carcinoma from 21 epidemiological studies. Cancer Epidemiology Biomarkers and Prevention 18, 1060-1069 (2009).'}, {'type': 'BACKGROUND', 'citation': 'Berrington De González, A. & Green, J. Comparison of risk factors for invasive squamous cell carcinoma and adenocarcinoma of the cervix: Collaborative reanalysis of individual data on 8,097 women with squamous cell carcinoma and 1,374 women with adenocarcinoma from 12 epidemiological studies. Int J Cancer 120, 885-891 (2007).'}, {'type': 'BACKGROUND', 'citation': 'Plummer, M. et al. Smoking and cervical cancer: pooled analysis of the IARC multi-centric case-control study. Cancer Causes and Control 14, 805-814 (2003).'}, {'type': 'BACKGROUND', 'citation': 'Collins, S., Rollason, T. P., Young, L. S. & Woodman, C. B. J. Cigarette smoking is an independent risk factor for cervical intraepithelial neoplasia in young women: A longitudinal study. Eur J Cancer 46, 405-411 (2010).'}, {'type': 'BACKGROUND', 'citation': "Tekalegn, Y. et al. High parity is associated with increased risk of cervical cancer: Systematic review and meta-analysis of case-control studies. Women's Health 18, (2022)."}, {'type': 'BACKGROUND', 'citation': 'Bezabih, M., Tessema, F., Sengi, H. & Deribew, A. Risk Factors Associated with Invasive Cervical Carcinoma among Women Attending Jimma University Specialized Hospital, Southwest Ethiopia: A Case Control Study. Ethiop J Health Sci 25, 345-352 (2015).'}, {'type': 'BACKGROUND', 'citation': 'McGraw, S. L. & Ferrante, J. M. Update on prevention and screening of cervical cancer. World J Clin Oncol 5, 744-752 (2014).'}, {'type': 'BACKGROUND', 'citation': 'Hwang, L. Y. et al. Factors That Influence the Rate of Epithelial Maturation in the Cervix in Healthy Young Women. Journal of Adolescent Health 44, 103-110 (2009).'}, {'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': 'World Health Organization. Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem. https://www.who.int/publications/i/item/9789240014107 (2020).'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization & International Agency for Research on Cancer. Global Cancer Observatory. https://gco.iarc.fr/today/home'}, {'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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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:\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 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."}, '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 for testing.'}, 'identificationModule': {'nctId': 'NCT07480902', 'briefTitle': 'Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Timser SAPI de CV'}, 'officialTitle': 'Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population', 'orgStudyIdInfo': {'id': 'PROT-ATSO-INV-011'}, 'secondaryIdInfos': [{'id': '1090', 'type': 'OTHER', 'domain': 'Ethics Committee of iPharma SA de CV'}]}, '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': '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', 'description': 'Physical examination and interview for obtaining a medical record of each participant', 'armGroupLabels': ['Screening for reactive cellular changes in the cervix']}, {'name': 'Liquid-based cytology', 'type': 'OTHER', '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', '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', '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', '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': ['Cervical biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14210', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Fátima R Ruiz-Rosales, Bachelor of Medicine', 'role': 'CONTACT', 'email': 'medico@preventix.mx', 'phone': '+52-56-3953-3339'}, {'name': 'Violeta G Jardines-Pérez', 'role': 'CONTACT', 'email': 'violeta.jardines@preventix.mx', 'phone': '+52-56-3230-7157'}, {'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'}, {'name': 'Fátima R Ruiz-Rosales, Bachelor of Medicine', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Consultorio Médico TIMSER', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Mercedes Gutiérrez-Smith, Bachelor of Arts in History', 'role': 'CONTACT', 'email': 'mercedes@atsopharma.com', 'phone': '+52-55-9057-1000'}, {'name': 'Fátima R Ruiz-Rosales, Bachelor of Medicine', 'role': 'CONTACT', 'email': 'medico@preventix.mx', 'phone': '+52-56-3953-3339'}], 'overallOfficials': [{'name': 'Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultorio Médico TIMSER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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'}}}}