Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cytology.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ScreenEC: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
Overview
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).
Interventions
- Device Cytology
Two cervical samples are collected using a cervical brush or swab, following the standard procedure for cervical cytology. Cells are taken from the cervix using a brush/spatula during a gynecological exam. (1) The first sample is kept in the clinical center's pathology department for examination. (2) The second sample is sent to MiMARK's facilities for the investigational project, where it will be processed and stored for future cohort selection and analysis.
Primary outcome measures
- Regulatory Requirements Study [Time frame: 12 months]
- Algorithm training with Proprietary Antibodies [Time frame: 12 months]
- Algorithm testing and freeze [Time frame: 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
- Hospital Universitari Campus Vall d'Hebron — Barcelona
Identifiers
NCT: NCT07148154 · ScreenEC