NCT Number: NCT07480902
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
Interested in participating?
Request Info18 year–85 year
Female
Interventional
Not applicable
Mexico City, 14210, Mexico
Location status: Recruiting
Fátima R Ruiz-Rosales, Bachelor of Medicine
CONTACT
Fátima R Ruiz-Rosales, Bachelor of Medicine
SUB_INVESTIGATOR
Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol
PRINCIPAL_INVESTIGATOR
Violeta G Jardines-Pérez
CONTACT
Víctor M Vargas-Aguilar, MD in OB/GY & Gynecol Oncol
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Discontinuation Criteria:
Physical examination and interview for obtaining a medical record of each participant
Screening test for cervical precursor lesions and/or cancer. LBC is a procedure in which a cervical smear is examined under the microscope
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 detection is performed using a cervical swab
A diagnostic procedure to visually examine the cervix, vagina, and vulva with a colposcope
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
Time frame: 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.
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.
Time frame: 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
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: During the first visit (Day 1).
The study physician will record the participants date of birth. Age (in years) will be calculated in reference to the first visit date.
Time frame: During the first visit (Day 1).
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.
Time frame: During the first visit (Day 1).
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.
Time frame: During the first visit (Day 1) by clinical interview.
Ethnicity data will be obtained through clinical interview. Ethnicity is linked to cultural expression and identity.
Ethnicity options:
Hispanic/Latino. Not Hispanic/Latino.
Time frame: During the first visit (Day 1) by clinical interview.
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.
Time frame: During the first visit (Day 1) by clinical interview.
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.
Time frame: During the first visit (Day 1) by clinical interview.
The age at sexual debut -in years- will be obtained during the clinical interview. The age will be recorded in years.
Time frame: During the first visit (Day 1) by clinical interview.
The number of years since menarche to sexual debut will be calculated as follows:
NYSMSD = Age of Sexual Debut - Age of Menarche.
Time frame: During the first visit (Day 1) by clinical interview.
The number of lifetime sexual partners of the participants will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
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.
Time frame: During the first visit (Day 1) by clinical interview.
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.
Time frame: During the first visit (Day 1) by clinical interview.
The number of abortions will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
The number of vaginal deliveries will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
The number of Caesarean sections will be obtained during the clinical interview.
Time frame: During the first visit (Day 1) by clinical interview.
The number of cigarettes per week will be obtained during the clinical interview.
Time frame: 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.
This test detects the human biomarker p16INK4a widely used for assessing HPV infection in a cervical biopsy.
P16 IHC results:
Positive. Negative. Inconclusive.
Contact information is provided by the study sponsor or research team.
Fátima R Ruiz-Rosales, Bachelor of Medicine
CONTACT
Mercedes Gutiérrez-Smith, Bachelor of Arts in History
CONTACT
Timser SAPI de CV
Industry
Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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