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| ID | Type | Description | Link |
|---|---|---|---|
| 1090 | Other Identifier | Ethics Committee of iPharma SA de CV |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Cervical biopsy | Other | Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical examination | Procedure | Physical examination and interview for obtaining a medical record of each participant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the first visit (Day 1). |
| Body Mass Index BMI (numeric) |
| Measure | Description | Time Frame |
|---|---|---|
| p16 immunohistochemistry results (dichotomic) | This test detects the human biomarker p16INK4a widely used for assessing HPV infection in a cervical biopsy. P16 IHC results: Positive. Negative. Inconclusive. | 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. |
Inclusion Criteria:
Exclusion Criteria:
Discontinuation Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol | Consultorio Médico TIMSER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultorio Médico TIMSER | Recruiting | Mexico City | Mexico City | 14210 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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). | ||
| 37201194 | Background | 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. | |
| Background | 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. OncologÃa (Ecuador) (2017) doi:10.33821/227. | ||
| 3203132 |
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All de-identified individual participant data will be publicly available in the supplementary material associated with the scientific publication.
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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.
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Given this is a screening study:
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.
| Liquid-based cytology | Other | 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 | Other | 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 | Other | HPV DNA detection is performed using a cervical swab |
|
| Colposcopy | Diagnostic Test | A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope |
|
| Histopathology | Diagnostic 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 |
|
| 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. | 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. | 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. |
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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | During the first visit (Day 1) by clinical interview. |
| Number of abortions (numeric) | The number of abortions will be obtained during the clinical interview. | 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. | 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. | 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. | During the first visit (Day 1) by clinical interview. |
| Background |
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| Background | 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). |
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| 28155005 | Background | Akinlotan M, Bolin JN, Helduser J, Ojinnaka C, Lichorad A, McClellan D. Cervical Cancer Screening Barriers and Risk Factor Knowledge Among Uninsured Women. J Community Health. 2017 Aug;42(4):770-778. doi: 10.1007/s10900-017-0316-9. |
| Background | 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). |
| Background | 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). |
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| 27487071 | Background | Mitra A, Tzafetas M, Lyons D, Fotopoulou C, Paraskevaidis E, Kyrgiou M. Cervical intraepithelial neoplasia: screening and management. Br J Hosp Med (Lond). 2016 Aug 2;77(8):C118-23. doi: 10.12968/hmed.2016.77.8.C118. No abstract available. |
| Background | 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). |
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| Background | 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). |
| Background | World Health Organization & International Agency for Research on Cancer. Global Cancer Observatory. https://gco.iarc.fr/today/home |
| Background | 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. |
| ID | Term |
|---|---|
| D065309 | Atypical Squamous Cells of the Cervix |
| D002578 | Uterine Cervical Dysplasia |
| D000081483 | Squamous Intraepithelial Lesions |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D061809 | Human Papillomavirus DNA Tests |
| D003127 | Colposcopy |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D005821 | Genetic Techniques |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
Not provided
Not provided