EndometriosisRNA-EndoDxNCT06907303
RNA Assays for Endometriosis Detection and Diagnosis
An observational study of Endometriosis, run by Wren Laboratories LLC at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- EndoDx
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Adult
Study population: Women with high suspicion of endometriosis and women undergoing surgery for benign cervical disease.
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: Development and Evaluation of RNA-based Markers for Detecting and Diagnosing Endometriosis
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.
Read the 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
- Conditions
- Endometriosis
- Being tested
- EndoDx
- Keywords
- Endometriosis, Diagnosis, Gene Expression, PCR
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoDxDiagnostic test
PCR assay for Endometriosis diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Women with suspected endometriosis undergoing laparoscopy to provide tissue for pathological diagnosis of the disease. Receives: Diagnostic Test: EndoDx | |
| Control | Women undergoing surgery for benign cervical disease. Receives: Diagnostic Test: EndoDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a gene signature that detects endometriosis
Gene expression levels in samples from endometriosis subjects and controls
Measured: 12-18 months
Secondary outcomes (1)
Assess the diagnostic utility of the gene signature to differentiate between endometriosis and controls
Algorithmic analysed normalized gene expression levels in samples from endometriosis subjects and controls
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jan 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wren Laboratories LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cape Town
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907303
- Sponsor's protocol ID
- WrenEndoMstudy 01
- Acronym
- RNA-EndoDx
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of RNA-based Markers for Detecting and Diagnosing Endometriosis
- ClinicalTrials.gov ID
- NCT06907303
- Acronym / sponsor ID
- RNA-EndoDx / WrenEndoMstudy 01
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Diagnosis, Gene Expression, PCR
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wren Laboratories LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Cape Town
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Diagnostic Test: EndoDxWomen with suspected endometriosis undergoing laparoscopy to provide tissue for pathological diagnosis of the disease. |
| Control | – | Diagnostic Test: EndoDxWomen undergoing surgery for benign cervical disease. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with high suspicion of endometriosis and women undergoing surgery for benign cervical disease.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoDxPCR assay for Endometriosis diagnosis | Diagnostic test | Control, Endometriosis |
Primary outcome
Develop a gene signature that detects endometriosis
Time frame: 12-18 months
Gene expression levels in samples from endometriosis subjects and controls
1 secondary outcome
Assess the diagnostic utility of the gene signature to differentiate between endometriosis and controls
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Wren Laboratories LLC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a gene signature that detects endometriosis (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.