Non-invasive cervical fluid test to screen high-risk women for endometrial cancer
ScreenEC: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
This study will test CYTOMARK, a non-invasive ELISA that measures protein biomarkers in cervical fluid to see if it can detect endometrial cancer in post-menopausal women with abnormal uterine bleeding or other risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | MiMARK Diagnostics, S.L. Industry-sponsored |
| Locations | 2 sites (L'Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Trial ID | NCT07148154 on ClinicalTrials.gov |
What this trial studies
The study enrolls post-menopausal women with abnormal uterine bleeding or defined risk factors who provide cervical cytology samples for analysis. CYTOMARK measures a defined panel of protein biomarkers in cervical fluid using ELISA and the team will develop and lock an algorithm to identify endometrial cancer. Test results will be compared with clinical diagnostic workup, including imaging and histology when available, to determine accuracy. The observational study is being conducted at Hospital Universitari de Bellvitge and Hospital Vall d'Hebron in Barcelona.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women (no menstruation for ≥1 year) with abnormal uterine bleeding and either endometrial thickness >3 mm on transvaginal ultrasound or one or more risk factors such as BMI ≥30, tamoxifen use, HRT, Lynch syndrome, or BRCA mutation.
Not a fit: Women who are pre-menopausal, already diagnosed with endometrial cancer, or who have active pelvic infections or active viral infections (untreated hepatitis B/C or HIV) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the test could enable earlier, easier detection of endometrial cancer and reduce the need for invasive diagnostic procedures.
How similar studies have performed: Early pilot studies using cervical or uterine samples with protein or molecular markers have shown promise, but large-scale clinical validation of non-invasive diagnostics for endometrial cancer is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1 - Post-menopausal women (≥1 year without menstruation) with AUB who present with: Endometrium \> 3mm by transvaginal ultrasound, OR Endometrium ≤ 3mm who meet at least one of the following criteria: Persistent symptoms (more than one episode of metrorrhagia) Heterogenous endometrium on transvaginal ultrasonography Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation. \- 2 - Obtaining written informed consent Exclusion Criteria: * 1 - Women with an active pelvic infection. 2 - Women who have had viral infections with evidence of active and latent disease such as Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona and 1 other locations
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitari Campus Vall d'Hebron — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Gil-Moreno, MD, PhD — Hospital Universitari Campus Vall d'Hebron
- Study coordinator: Antonio Gil-Moreno, MD, PhD
- Email: antonio.gil@vallhebron.cat
- Phone: 934893066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.