Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Mexico
Consultorio Médico TIMSER
RECRUITING
Mexico City
Contact Information
Primary
Mercedes Gutiérrez-Smith, Bachelor of Arts in History
mercedes@atsopharma.com
+52-55-9057-1000
Backup
Fátima R Ruiz-Rosales, Bachelor of Medicine
medico@preventix.mx
+52-56-3953-3339
Time Frame
Start Date: 2026-02-03
Estimated Completion Date: 2026-06
Participants
Target number of participants: 558
Treatments
Other: Screening for reactive cellular changes in the cervix
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)
Other: Cervical biopsy
Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied
Related Therapeutic Areas
Sponsors
Leads: Timser SAPI de CV