Endometrial Cancer
Conditions
Keywords
Endometrial Cancer, IVD, In-vitro Diagnostics, Endometrial adenocarcinoma, diagnostics
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).
Interventions
DEVICECytology
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.
Sponsors
Hospital Vall d'Hebron
MiMARK Diagnostics, S.L.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regulatory Requirements Study | 12 months | Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed ScreeEC's ELISA test. |
| Algorithm training with Proprietary Antibodies | 12 months | Train the current ScreenEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination detect EC in post- menopausal women with AUB using MiMARK's proprietary antibodies. |
| Algorithm testing and freeze | 12 months | To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB. |
Countries
Spain
Contacts
Primary ContactAntonio Gil-Moreno, MD, PhD
Backup ContactEva Colás, PhD
Outcome results
None listed