RNA Assays for Endometriosis Detection and Diagnosis

NCT06907303 | Enrolling By Invitation

• 1 other identifier: WrenEndoMstudy 01
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Endometriosis

Keywords

Endometriosis; Diagnosis; Gene Expression; PCR

Outcome Measures

Primary Outcomes (1)

• Develop a gene signature that detects endometriosis

  Gene expression levels in samples from endometriosis subjects and controls

  12-18 months

Secondary Outcomes (1)

• Assess the diagnostic utility of the gene signature to differentiate between endometriosis and controls

  6 months

Study Arms (2)

Endometriosis

Women with suspected endometriosis undergoing laparoscopy to provide tissue for pathological diagnosis of the disease.

Diagnostic Test: EndoDx

Control

Women undergoing surgery for benign cervical disease.

Diagnostic Test: EndoDx

Interventions

EndoDx DIAGNOSTIC_TEST

PCR assay for Endometriosis diagnosis

Control; Endometriosis

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with high suspicion of endometriosis and women undergoing surgery for benign cervical disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wren Laboratories LLC: lead
• University of Cape Town: collaborator

Study Sites (2)

Wren Laboratories

Branford, Connecticut, 06405, United States

Location

University of Cape Town

Cape Town, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, saliva

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 2, 2025
• Study Start: January 1, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ZA (1)