RNA Assays for Endometriosis Detection and Diagnosis

NCT06907303 · tracked via the Priya Life Science USA tracker

Sponsor

Wren Laboratories LLC

Phase

Observational

Started

2024-01-01

Last updated

2025-04-02

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

EndoDx

EndoDx: PCR assay for Endometriosis diagnosis

Study summary

Endometriosis is a common disease that affects up to 10% of women of reproductive age. Diagnosis, however, is typically delayed (up to 12 years) and is usually made after surgery. A key unmet need therefore is an accurate biomarker that can be used to detect the disease early. This study is a prospective trial to identify candidate mRNA-markers which can be used to aid in the diagnosis of this disease. It is a discovery/validation study that will identify and confirm a gene expression panel that is specific for endometriosis and provides a non-invasive tool for future use.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

35 Years

Healthy volunteers

Inclusion Criteria: For the endometriosis cohort * a history of infertility more than 1 year * age 20-35 years * normal liver and kidney function, without gynaecological and other systemic disease Inclusion criteria for controls include normo-ovulatory history, aged between 20-35 years, who exhibit normal liver and kidney function, and do not have any systemic diseases including autoimmune disease. \- Exclusion Criteria: For the endometriosis cohort * polycystic ovary syndrome, hyperprolactinemia * severe cardiovascular system, liver, kidney, and hematopoietic system disease * autoimmune disease * uterine fibroids, endometritis, non-vegetative ovarian cysts, ovarian malignancies, and internal genital tuberculosis Exclusion criteria for the controls includes gynaecological malignancies and genital tuberculosis. \-

Primary outcome measure(s)

Develop a gene signature that detects endometriosis — 12-18 months
Gene expression levels in samples from endometriosis subjects and controls

Trial sites (2)

Facility	City	Region	Status
Wren Laboratories	Branford	Connecticut
University of Cape Town	Cape Town	South Africa

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Other trials for the same condition

Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology) Active, not recruiting

Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck) Recruiting

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain Active, not recruiting

Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis Starting soon

Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06907303 on ClinicalTrials.gov ↗ ← All trials in the USA