Overview
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
Description
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:
- Explanation of the study and its procedures. Only participants that give their written Informed Consent will be enrolled in the study.
- Interview and physical examination to obtain a medical record. The interview will collect information related to known risks factors for cervical lesions.
- Venipuncture to obtain a blood sample.
- Colposcopy to obtain a cervical smear and a colposcopic diagnosis. The cervical smear will be used to perform liquid-based cytology and HPV detection.
- 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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
