EndometriosisSTERONLINENCT06820450
Pilot Study to Characterize the Endometriosis Steroidome and Its Link to Endocrine Disruptors and Vaginal Dysbiosis
An observational study of Endometriosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Endometriosis is a systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Blood test, urine sample and vaginal sample
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 1 Jul 2027
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The STERONLINE study population will be made up of women aged between 18 years and 45 years * 45 patients with endometrioma * 45 patients without endometrioma
Who may be able to join
- Women aged 18 to 45
- Free, informed and written consent from the patient to participate in the study
- Good understanding of the French language
- Patient affiliated to or benefiting from a social security or similar scheme
- Specific inclusion criteria for each group:
- Group 1. Controls.
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- Women with no laparoscopically confirmed signs suggestive of deep endometriosis.
- No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis.
- Group 2. Cases of deep endometriosis.
- Newly diagnosed women (less than 12 months).
- Severe, deep endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings).
Who cannot join
- Intercurrent diagnosis of pregnancy.
- Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
- Acute infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Stéphane PLOTEAU, 0240087684, stephane.ploteau@chu-nantes.fr
About this study
Official title: STERONLINE: Steroidome and Exposome of Endometriosis Single-center Case-control Study
Endometriosis is a systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. The etiology and pathophysiology of endometriosis is not completely understood to support effective treatment and prevention strategies. Despite the steroid dependency, little is known concerning the underlying metabolism of estrogen and other tightly related steroids. Moreover, shortening the long diagnostic delays is a major priority in endometriosis research.
Read the detailed description
The main aim of the study will be to develop a global steroidomics analytical strategy " fit-for-purpose" to improve the knowledge of endometriosis pathophysiology and boost the identification of diagnostic biomarkers.
Therefore, in a first step, a new analytical method will be developed adapting state-of-the-art liquid chromatography coupled to high resolution mass spectrometry (LC-HRMS) approaches for steroids and its metabolites towards endometriosis research. The investigators will ensure the characterization of established steroids and its metabolites known to be relevant to endometriosis, but also expand the panel with non-targeted methods to identify phase-1 and -2 metabolites potentially informing of novel steroidogenic pathways in serum and urine.
In a second phase, a case-control study will be conducted to apply the strategy in a sample of women with and without endometriosis. In a third step, the investigators will explore statistical differences in steroid profiles among endometriosis groups and evaluate the discriminative performance.
The proposed method has large applications in endometriosis research and large potential to provide novel clues about the still poorly understood steroid metabolism disruption undergoing in endometriosis. Ultimately, non-invasive biomarker discovery in urine could revolutionize endometriosis diagnosis and management, allowing for earlier detection and personalized treatment strategies, ultimately improving the lives of individuals affected by this often overlooked but debilitating condition.
In parallel, the role of dysbiosis of the vaginal microbiota on hormonal alterations linked to endometriosis will be studied.
- Conditions
- Endometriosis
- Being tested
- Blood test, urine sample, vaginal sample
- Keywords
- Steroidome, exposome, LC-HRMS
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles
urine sampleOther
a 20 ml urine sample will be taken to analyze steroid profiles
vaginal sampleOther
to characterize the microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Controls (n=45) | * Women with no laparoscopically confirmed signs of deep endometriosis.
* No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis.
A blood test (2 x 5 ml dry tubes) and a 20 ml urine sample will be taken to analyze steroid profiles, as well as a vaginal sample to characterize the microbiota. Receives: Other: Blood test; Other: urine sample; Other: vaginal sample | |
| Group 2. Deep endometriosis (n = 90) | * 45 patients with endometriome
* 45 patients without endometriome Deep endometriosis confirmed by surgery or MRI Newly diagnosed women (less than 12 months).
* Severe, deep-seated endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings).
A blood test (2 x 5 ml dry tubes) and a 20 ml urine sample will be taken to analyze steroid profiles, as well as a vaginal sample to characterize the microbiota. Receives: Other: Blood test; Other: urine sample; Other: vaginal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify steroid profiles associated with endometriosis
Statistical associations between steroids and the presence of endometriosis.
Measured: Sampling at inclusion visit
Secondary outcomes (2)
Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.
Statistical difference between environmental chemical and steroid exposure profiles between subgroups of the study populations.
Measured: Sampling at inclusion visit
Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis
Presence of a specific bacterial community in the vaginal microbiota
Measured: Sampling at inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820450
- Sponsor's protocol ID
- RC24_0498
- Acronym
- STERONLINE
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STERONLINE: Steroidome and Exposome of Endometriosis Single-center Case-control Study
- ClinicalTrials.gov ID
- NCT06820450
- Acronym / sponsor ID
- STERONLINE / RC24_0498
- Conditions
- Endometriosis
- Keywords
- Steroidome, exposome, LC-HRMS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Feb 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 systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. The etiology and pathophysiology of endometriosis is not completely understood to support effective treatment and prevention strategies. Despite the steroid dependency, little is known concerning the underlying metabolism of estrogen and other tightly related steroids. Moreover, shortening the long diagnostic delays is a major priority in endometriosis research.
Detailed description
The main aim of the study will be to develop a global steroidomics analytical strategy " fit-for-purpose" to improve the knowledge of endometriosis pathophysiology and boost the identification of diagnostic biomarkers.
Therefore, in a first step, a new analytical method will be developed adapting state-of-the-art liquid chromatography coupled to high resolution mass spectrometry (LC-HRMS) approaches for steroids and its metabolites towards endometriosis research. The investigators will ensure the characterization of established steroids and its metabolites known to be relevant to endometriosis, but also expand the panel with non-targeted methods to identify phase-1 and -2 metabolites potentially informing of novel steroidogenic pathways in serum and urine.
In a second phase, a case-control study will be conducted to apply the strategy in a sample of women with and without endometriosis. In a third step, the investigators will explore statistical differences in steroid profiles among endometriosis groups and evaluate the discriminative performance.
The proposed method has large applications in endometriosis research and large potential to provide novel clues about the still poorly understood steroid metabolism disruption undergoing in endometriosis. Ultimately, non-invasive biomarker discovery in urine could revolutionize endometriosis diagnosis and management, allowing for earlier detection and personalized treatment strategies, ultimately improving the lives of individuals affected by this often overlooked but debilitating condition.
In parallel, the role of dysbiosis of the vaginal microbiota on hormonal alterations linked to endometriosis will be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. Controls (n=45) | – | Other: Blood test, Other: urine sample, Other: vaginal sample* Women with no laparoscopically confirmed signs of deep endometriosis. * No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis. A blood test (2 x 5 ml dry tubes) and a 20 ml urine sample will be taken to analyze steroid profiles, as well as a vaginal sample to characterize the microbiota. |
| Group 2. Deep endometriosis (n = 90) | – | Other: Blood test, Other: urine sample, Other: vaginal sample* 45 patients with endometriome * 45 patients without endometriome Deep endometriosis confirmed by surgery or MRI Newly diagnosed women (less than 12 months). * Severe, deep-seated endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings). A blood test (2 x 5 ml dry tubes) and a 20 ml urine sample will be taken to analyze steroid profiles, as well as a vaginal sample to characterize the microbiota. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The STERONLINE study population will be made up of women aged between 18 years and 45 years * 45 patients with endometrioma * 45 patients without endometrioma
Key inclusion criteria (11 listed)
- Women aged 18 to 45
- Free, informed and written consent from the patient to participate in the study
- Good understanding of the French language
- Patient affiliated to or benefiting from a social security or similar scheme
- Group 1. Controls.
Key exclusion criteria (3 listed)
- Intercurrent diagnosis of pregnancy.
- Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
- Acute infection.
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 |
|---|---|---|
| Blood testA blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles | Other | Group 1. Controls (n=45), Group 2. Deep endometriosis (n = 90) |
| urine samplea 20 ml urine sample will be taken to analyze steroid profiles | Other | Group 1. Controls (n=45), Group 2. Deep endometriosis (n = 90) |
| vaginal sampleto characterize the microbiota. | Other | Group 1. Controls (n=45), Group 2. Deep endometriosis (n = 90) |
Primary outcome
Identify steroid profiles associated with endometriosis
Time frame: Sampling at inclusion visit
Statistical associations between steroids and the presence of endometriosis.
2 secondary outcomes
Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.
Time frame: Sampling at inclusion visit
Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis
Time frame: Sampling at inclusion visit
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 24 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Nantes University Hospital at 1 site in France.
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 11 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Stéphane PLOTEAU, PU-PH (02.40.08.76.84 ext. +33, Stéphane.ploteau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify steroid profiles associated with endometriosis (time frame: Sampling at inclusion visit). 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 24 Jun 2026.