Clinical trial NCT06192017: Development of a Molecular Diagnostic Tool for Endometrial Cancer.
Official title: Development of a Molecular Diagnostic Tool for Endometrial Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrium Cancer
Keywords: Endometrial Cancer, EC
Lead sponsor: MiMARK Diagnostics, S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Vall d'Hebron
First posted: 2024-01-05
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-menopausal women presenting AUB entering to the EC diagnostic process at the clinical consultancy or emergency room.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Regulatory Requirements Study
timeFrame: 12 months
measure: Algorithm training with Proprietary Antibodies
timeFrame: 12 months
measure: Algorithm testing and freeze
timeFrame: 12 months
Secondary outcomes:
measure: To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.
timeFrame: 12 months
measure: Evaluation of the performance of different models of WomEC to determine histological subtype.
timeFrame: 12 months
measure: Evaluation of the performance of WomEC to determine other prognostic factors of EC.
timeFrame: 12 months
measure: Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.
timeFrame: 12 months
Other outcomes:
Locations:
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Balearic Islands
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge - Hospital Duran i Reynals
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Guipuzcoa
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Materno Infantil de Gran Canaria
state: Las Palmas
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Campus Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Cadiz
country: Spain
facility: Hospital Universitario de Puerto Real
city: Castelló de la Plana
country: Spain
facility: Hospital General Universitari de Castelló
city: León
country: Spain
facility: Hospital Universitario de León
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Valencia
country: Spain
facility: Hospital General Universitari de València
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico de La Fe
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitari Campus Vall d'Hebron
name: Antonio Gil-Moreno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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