Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 2:11 AM
Study NCT ID:
NCT06907303
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-02
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RNA Assays for Endometriosis Detection and Diagnosis
Sponsor:
Wren Laboratories LLC
Organization:
Study Overview
Official Title:
Development and Evaluation of RNA-based Markers for Detecting and Diagnosing Endometriosis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RNA-EndoDx
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.
Detailed Description:
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 typically made after surgery. A key unmet need therefore is an accurate, non-invasive biomarker that can be used to detect the disease early.
We hypothesize that endometriosis-related circulating gene expression can be identified using transcriptomic and bioinformatics approaches and used to construct an accurate diagnostic tool for this condition.
The primary objective is to develop a gene signature that detects endometriosis. The hypothesis is that this disease is characterized by a set of genes that characterize endometriosis tumor biology.
The aim is to detect over-expressed genes (elevated mRNA expression) in endometriosis tissue. The goal is to identify 10-25 biomarker genes that are highly expressed to form a candidate biomarker panel.
Highly expressed genes will be determined against samples collected from age/menstrual stage matched controls. A bio-informatics approach will be used to identify these over-expressed genes. This form the basis of a potential diagnostic panel.
Per PICOT criteria:
* The target patient population are women aged 20-35 years with a pathological diagnosis of endometriosis.
* The intervention is sample collection at the time of diagnosis (tissue, blood, saliva)
* The comparison group are normo-ovulatory subjects (age 20-25 years) undergoing surgery for benign cervical lesions.
* The outcome is a gene signature that is associated with endometriosis.
* The follow-up time is one year.
The secondary objective is to test the diagnostic utility of the 10-25 gene panel. This will be undertaken using the retrospectively collected samples.
* Each of the highly expressed genes will be measured and quantified using an RT-PCR approach.
* Genes that are statistically over-expressed in the endometriosis samples will be selected for a PCR panel.
* The expression of genes in the PCR panel will be scored.
* Low scores will be related to "control" and higher scores to "endometriosis".
* The scores will be formally evaluated as a diagnostic (area under the curve analysis, accuracy, sensitivity and specificity metrics).
* A specific comparison will be made between the endometriosis cohort and the control cohort.
* The metrics for a successful assay are:
* Accuracy \>80%
* Sensitivity \>90%
* Specificity \>85%
* AUC \>0.8
We hypothesize that endometriosis-related circulating gene expression can be identified using transcriptomic and bioinformatics approaches and used to construct an accurate diagnostic tool for this condition.
The primary objective is to develop a gene signature that detects endometriosis. The hypothesis is that this disease is characterized by a set of genes that characterize endometriosis tumor biology.
The aim is to detect over-expressed genes (elevated mRNA expression) in endometriosis tissue. The goal is to identify 10-25 biomarker genes that are highly expressed to form a candidate biomarker panel.
Highly expressed genes will be determined against samples collected from age/menstrual stage matched controls. A bio-informatics approach will be used to identify these over-expressed genes. This form the basis of a potential diagnostic panel.
Per PICOT criteria:
* The target patient population are women aged 20-35 years with a pathological diagnosis of endometriosis.
* The intervention is sample collection at the time of diagnosis (tissue, blood, saliva)
* The comparison group are normo-ovulatory subjects (age 20-25 years) undergoing surgery for benign cervical lesions.
* The outcome is a gene signature that is associated with endometriosis.
* The follow-up time is one year.
The secondary objective is to test the diagnostic utility of the 10-25 gene panel. This will be undertaken using the retrospectively collected samples.
* Each of the highly expressed genes will be measured and quantified using an RT-PCR approach.
* Genes that are statistically over-expressed in the endometriosis samples will be selected for a PCR panel.
* The expression of genes in the PCR panel will be scored.
* Low scores will be related to "control" and higher scores to "endometriosis".
* The scores will be formally evaluated as a diagnostic (area under the curve analysis, accuracy, sensitivity and specificity metrics).
* A specific comparison will be made between the endometriosis cohort and the control cohort.
* The metrics for a successful assay are:
* Accuracy \>80%
* Sensitivity \>90%
* Specificity \>85%
* AUC \>0.8
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: