NCT07148154 Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
| NCT ID | NCT07148154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MiMARK Diagnostics, S.L. |
| Condition | Endometrial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2024-06-24 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CYTOMARK, a non-invasive in vitro diagnostic (IVD) test measuring a defined panel of protein biomarkers in cervical fluid, can accurately detect endometrial cancer in both symptomatic and asymptomatic women at high risk for the disease. The aim of the study consists in validating CYTOMARK's ELISA test, creating and freezing an algorithm detect EC in post-menopausal women with abnormal uterine bleeding (AUB).
Eligibility 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.
Contact & Investigator
Antonio Gil-Moreno, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Universitari Campus Vall d'Hebron
Frequently Asked Questions
Who can join the NCT07148154 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07148154 currently recruiting?
Yes, NCT07148154 is actively recruiting participants. Contact the research team at antonio.gil@vallhebron.cat for enrollment information.
Where is the NCT07148154 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain, Barcelona, Spain.
Who is sponsoring the NCT07148154 clinical trial?
NCT07148154 is sponsored by MiMARK Diagnostics, S.L.. The principal investigator is Antonio Gil-Moreno, MD, PhD at Hospital Universitari Campus Vall d'Hebron. The trial plans to enroll 3,000 participants.
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