Pap smear versus a three-marker blood test to find cervical precancer and cancer

Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening For Detecting Reactive Cellular Changes In The Cervix In An Open Population

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 558 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Female
• Sponsor: Timser SAPI de CV (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT07480902 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Mexico City, Mexico City

• 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

Conditions I) Atypical Squamous Cells of Undetermined Significance; II) Atypical Glandular Cells of Uncertain Significance; III) Cervical Intraepithelial Neoplasia, CIN-1, CIN-2, CIN-3; IV) Low-grade Squamous Intraepithelial Lesion; V) High-grade Squamous Intraepithelial Lesion; VI) Cervical Cancer; Cervical precursor lesions; LSIL