Pap smear versus a three-marker blood test to find cervical precancer and cancer
Official title: Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population
Run by Timser SAPI de CV · NCT07480902 · Data updated 2026-11-12
This tests whether a blood test that measures three molecular markers can find cervical precursor lesions and cancer as well as the Pap smear in women 18 to 85.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Women only |
| Enrollment | 558 (estimated) |
| Sponsor | Timser SAPI de CV Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mexico City, Mexico City) |
| Status | Recruiting |
| Started | February 3, 2026 |
| Main results expected | April 2026 |
| Study ends | June 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07480902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–85 in good general health who can fast 6–12 hours, refrain from sexual intercourse 24 hours before testing, are not pregnant, and have not had a hysterectomy are ideal candidates.
✕Probably not a fit
People who are pregnant, menstruating, have had a subtotal/total/radical hysterectomy, are on active oncologic treatment, or have known HIV or hepatitis infection are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women aged 18–85 attend two clinic visits to compare liquid-based cytology (Pap smear) with a molecular screening blood test that measures three human biomarkers. At the first visit participants give informed consent, complete an interview and physical exam, have blood drawn, undergo colposcopy with a cervical smear for cytology and HPV DNA testing, and receive a biopsy only if a lesion is seen. Colposcopy is performed for all participants and histopathology is done for those biopsied; test sensitivity, specificity, and predictive values will be calculated against these references. Statistical comparisons between the molecular panel, HPV testing, and liquid-based cytology will be made using methods such as the DeLong test.
Why it matters
Potential benefit: If successful, the blood-based molecular screening could provide a less invasive or complementary way to detect cervical precursor lesions and cancer, potentially improving early detection.
How similar studies have gone: HPV DNA testing and liquid-based cytology are well-established for cervical screening, while blood-based molecular biomarker panels for detecting cervical precursor lesions are novel and have limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Consultorio Médico TIMSER
Mexico City, Mexico City, Mexico Recruiting
Study contacts
- Principal investigator: Leopoldo E Gatica-Galina, MD in OB/GY & Gynecol Oncol — Consultorio Médico TIMSER
- Study coordinator: Mercedes Gutiérrez-Smith, Bachelor of Arts in History
- Email: mercedes@atsopharma.com
- Phone: +52-55-9057-1000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.