Available in Mexico
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.
558Patients around the world