Testing a non-invasive cervical fluid test for endometrial cancer screening
Tests a non-invasive cervical fluid test to detect endometrial cancer in high-risk women.
Plain-language title generated from the registry record
Registry title: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Key facts
- Where
- Barcelona and L'Hospitalet de Llobregat, SpainSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women after menopause who have unusual bleeding from the uterus and may be at higher risk of womb (endometrial) cancer. A fluid sample from the cervix is tested for protein markers.
- Age
- 40 Years and older
- Sex
- Women only
- Disease stage
- Post-menopausal women (at least 1 year without a period) with unusual uterine bleeding. On vaginal ultrasound, the womb lining is thicker than 3mm, or 3mm or thinner with extra signs: more than one bleeding episode, a uneven lining, or a risk factor.
- Earlier treatment
- Not stated, except that past Hepatitis C is allowed if it was successfully treated and the virus has not been seen in the last year.
Main reasons for not taking part
- Active pelvic infection
- Active or latent viral infection such as Hepatitis B, Hepatitis C or HIV
- Not giving written informed consent
Read by machine on 12 November 2026.
Where in Spain
- Hospital Universitari Campus Vall d'HebronBarcelona, SpainContact: Antonio Gil-Moreno, MD, PhDTaking people
- Hospital Universitari de BellvitgeL'Hospitalet de Llobregat, SpainContact: Laura Costas, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- MiMARK Diagnostics, S.L.
- Trial code
- NCT07148154
- Record updated
- 29 August 2025
- Original description
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).Read full original descriptionShow less
ScreenEC: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
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).
Inclusion: 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: 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.