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

Официальное название

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

Обзор

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

Подробное описание

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:

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 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.

Вмешательства

• Процедура Physical examination
  Physical examination and interview for obtaining a medical record of each participant
• Другое 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
• Другое 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
• Другое HPV DNA test
  HPV DNA detection is performed using a cervical swab
• Диагностический тест Colposcopy
  A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope
• Диагностический тест 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

Первичные конечные точки

• Liquid-based Cytology results (categorical) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Вторичные конечные точки (12)

• Age (numeric) [Срок оценки: During the first visit (Day 1).]
• Body Mass Index BMI (numeric) [Срок оценки: During the first visit (Day 1).]
• Blood pressure (numeric) [Срок оценки: During the first visit (Day 1).]
• Ethnicity (categorical) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Race (categorical) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Age at Menarche (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Age at sexual debut (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Number of years since menarche to sexual debut (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Number of lifetime sexual partners (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Number of years since last cytology (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Number of years since colposcopy (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]
• Number of abortions (numeric) [Срок оценки: During the first visit (Day 1) by clinical interview.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 for testing.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Скрининг

Центры проведения

Мексика · 1 центр

• Consultorio Médico TIMSER — Mexico City

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 32915499

Идентификаторы

NCT: NCT07480902 · PROT-ATSO-INV-011 · 1090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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