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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-EXT-886 | Other Identifier | Ethics Committee of Medica Sur |
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The study did not start, i.e., no participants were enrolled, because the Mexican Regulatory Authority (COFEPRIS) did not authorize the amendments to the protocol.
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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
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:
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 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). |
|
| Histopathology of 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liquid-based Cytology LBC results (categorical) | 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. 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 results (dichotomic) | 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 are as follows: Biomarker 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. | 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. Negative HPV test: Only if none of the fifteen genotypes are detected. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | 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 |
| 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 | Affiliation | Role |
|---|---|---|
| Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol | Clinica Reina Madre Metepec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Reina Madre Metepec | San Mateo Atenco | State of Mexico | 52105 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33380887 | Background | Serdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15. | |
| 26458884 | Background | Rozemeijer K, Penning C, Siebers AG, Naber SK, Matthijsse SM, van Ballegooijen M, van Kemenade FJ, de Kok IM. Comparing SurePath, ThinPrep, and conventional cytology as primary test method: SurePath is associated with increased CIN II+ detection rates. Cancer Causes Control. 2016 Jan;27(1):15-25. doi: 10.1007/s10552-015-0678-1. Epub 2015 Oct 12. |
| Label | URL |
|---|---|
| World Health Organization \& International Agency for Research on Cancer. Global Cancer Observatory | View source |
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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. |
|
|
| 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. | 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). Biopsies will be drawn only from women with positive colposcopy results. Histopathology is the gold standard for cervical cancer diagnosis. |
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 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.
| During the first visit (Day 1). |
| Ethnicity | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | The number of abortions will be obtained during the clinical interview. | During the first visit (Day 1) by clinical interview. |
| Number of vaginal deliveries | 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 | 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 | The number of cigarettes per week will be obtained during the clinical interview. | During the first visit (Day 1) by clinical interview. |
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| ID | Term |
|---|---|
| D065309 | Atypical Squamous Cells of the Cervix |
| D002578 | Uterine Cervical Dysplasia |
| 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
Not provided
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D061809 | Human Papillomavirus DNA Tests |
| D003127 | Colposcopy |
| D001706 | Biopsy |
| 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 |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D013048 | Specimen Handling |
Not provided
Not provided