Endometrium Cancer
Conditions
Keywords
Endometrial Cancer, EC
Brief summary
WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).
Interventions
DIAGNOSTIC_TESTWomEC
The study will collect pipelle biopsies from post-menopausal women presenting with AUB entering to the EC diagnostic process at the clinical consultancy or emergency room. In the study an endometrial biopsy by aspiration will be collected (i.e., pipelle biopsy) and it will be used for (1) diagnostic purposes following current procedures (i.e., pathological examination and diagnosis); (2) placed in a collection tube for WomEC test.
Sponsors
Hospital Vall d'Hebron
MiMARK Diagnostics, S.L.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Post-menopausal women (≥1 year without menstruation) with AUB who present with: 1. Endometrium \> 3mm by transvaginal ultrasound, OR 2. Endometrium ≤ 3mm who meet at least one of the following criteria: i. Persistent symptoms (more than one episode of metrorrhagia) ii. Heterogenous endometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation. * Obtaining written informed consent
Exclusion criteria
* Women with an active pelvic infection. * 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 WomEC's ELISA test. |
| Algorithm training with Proprietary Antibodies | 12 months | Train the current WomEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination to rule out 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy. | 12 months | Test the ability of WomEC to discriminate between EC and non-EC patients. |
| Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia. | 12 months | Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to diagnose endometrial atypical hyperplasia. |
| Evaluation of the performance of different models of WomEC to determine histological subtype. | 12 months | Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine an histological subtype. |
| Evaluation of the performance of WomEC to determine other prognostic factors of EC. | 12 months | Calculate the sensitivity, specificity, accuracy, precision, and clinical validity of WomEC to determine other prognostic factors of EC. |
Countries
Spain
Outcome results
None listed