Clinical trial · Observational
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
ScreenEC: Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Consultancy participants
- description
- Eligible participants are postmenopausal women presenting with abnormal uterine bleeding (AUB) in a clinical consultation or primary care setting, for whom a cytology procedure is performed. Cervical samples must be obtainable directly during the consultation at clinical centers with prior Ethics Committee approval. Only participants who meet all inclusion criteria and none of the exclusion criteria will be enrolled
- interventionNames
- Device: Cytology
Primary outcomes (3)
- measure
- Regulatory Requirements Study
- timeFrame
- 12 months
- description
- Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed ScreeEC's ELISA test.
- measure
- Algorithm training with Proprietary Antibodies
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available