EndometriosisENDOmiARNNCT04728152
Evaluation of miRNAs in Endometriosis
An observational study of Endometriosis and Endometriosis Fertility, run by Groupe expert en endometriose-6 centre expert en endometriose at 1 site in France.
Trial summary
We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA)… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis Fertility, Endometriosis-related Pain
- What is being tested?
- Blood and salivar test
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2021to 1 Jan 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 43 years
- Women only
- Adult
Study population: The study population consists of women between the ages of 18 and 43 with a formal endometriosis diagnosis or suspicion of endometriosis. Patients in the study are already receiving routine medical (PMA) or surgical care in the Gynecology-Obstetrics and Reproductive Medicine Department of the hospital. All of these patients already benefit from a validation of therapeutic indications in a multidisciplinary consultation meeting (medical-surgical RCP or fertility). The patients concerned by the study are treated without any change in the course of care, nor modification of the therapeutic indications, nor modification of the diagnostic tests (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS.
Who may be able to join
- Patient aged 18 to 43 years old,
- Patient has dated and signed the consent form,
- Patient affiliated with the French health care system,
- Patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data,
- Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care),
- Patient who has had a pelvic MRI,
- Patient who completed the symptom and quality of life questionnaires
Who cannot join
- Pregnant patient,
- Patient infected with the human immunodeficiency virus (HIV),
- Patient with significant difficulties in reading or writing the French language,
- Patient with a personal history of cancer,
- Patient unable to comply with study and/or follow-up procedures,
- Patient who has objected to the collection of her data.
- Patient participating in another clinical research study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Sofiane Bendifallah
Paris, 75020
SOFIANE BENDIFALLAH, 0156015410, sofiane.bendifallah@aphp.fr
About this study
We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.
- Being tested
- Blood and salivar test
- Keywords
- endometriosis, miRNA
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and salivar testOther
Saliva samples will be taken (concomitant with a visit carried out as part of routine care):
- At the pre-therapy visit (t3),
- At the post-treatment visit (at 3-6 weeks).
Blood samples will be taken at two stages (concomitant with a blood test performed as part of routine care):
- At the pre-therapy visit (t3),
- At the post-treatment visit (at 3-6 weeks).
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the evolution of miRNA expression (blood and salivary)
Measured: 1 month
Secondary outcomes (4)
To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;
Measured: 1 month
To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;
Measured: 1 time
Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;
Measured: 1 time
Describe the relationship between miRNA expression (blood and salivary) and the level of ovarian reserve, as estimated by the AMH assay in patients of childbearing age ;
Measured: 1 time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start27 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Groupe expert en endometriose-6 centre expert en endometriose
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofiane Bendifallah, Groupe expert en endometriose-6 centre expert en endometriose
- Investigators
- EMILE DARAI, PROF, Study director, Centre Expert En Endométriose (C3E)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728152
- Sponsor's protocol ID
- n° Id-RCB 2020-A03297-32
- Acronym
- ENDOmiARN
- Status last verified
- Jan 2021
- First submitted
- 23 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dabi Y, Suisse S, Marie Y, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Forlani S, Bouteiller D, Touboul C, Puchar A, Bendifallah S, Darai E. New class of RNA biomarker for endometriosis diagnosis: The potential of salivary piRNA expression. Eur J Obstet Gynecol Reprod Biol. 2023 Dec;291:88-95. doi: 10.1016/j.ejogrb.2023.10.015. Epub 2023 Oct 13.
PubMed 37857147
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of miRNAs in Endometriosis
- ClinicalTrials.gov ID
- NCT04728152
- Acronym / sponsor ID
- ENDOmiARN / n° Id-RCB 2020-A03297-32
- Keywords
- endometriosis, miRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Groupe expert en endometriose-6 centre expert en endometrioseUniversity, hospital or other
- Study start
- 27 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 28 Jan 2021 (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.
We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study population consists of women between the ages of 18 and 43 with a formal endometriosis diagnosis or suspicion of endometriosis. Patients in the study are already receiving routine medical (PMA) or surgical care in the Gynecology-Obstetrics and Reproductive Medicine Department of the hospital. All of these patients already benefit from a validation of therapeutic indications in a multidisciplinary consultation meeting (medical-surgical RCP or fertility). The patients concerned by the study are treated without any change in the course of care, nor modification of the therapeutic indications, nor modification of the diagnostic tests (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS.
Key inclusion criteria (7 listed)
- Patient aged 18 to 43 years old,
- Patient has dated and signed the consent form,
- Patient affiliated with the French health care system,
- Patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data,
- Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care),
Key exclusion criteria (7 listed)
- Pregnant patient,
- Patient infected with the human immunodeficiency virus (HIV),
- Patient with significant difficulties in reading or writing the French language,
- Patient with a personal history of cancer,
- Patient unable to comply with study and/or follow-up procedures,
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 and salivar testSaliva samples will be taken (concomitant with a visit carried out as part of routine care): * At the pre-therapy visit (t3), * At the post-treatment visit (at 3-6 weeks). Blood samples will be taken at two stages (concomitant with a blood test performed as part of routine care): * At the pre-therapy visit (t3), * At the post-treatment visit (at 3-6 weeks). | Other | – |
Primary outcome
Describe the evolution of miRNA expression (blood and salivary)
Time frame: 1 month
4 secondary outcomes
To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;
Time frame: 1 month
To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;
Time frame: 1 time
Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;
Time frame: 1 time
Describe the relationship between miRNA expression (blood and salivary) and the level of ovarian reserve, as estimated by the AMH assay in patients of childbearing age ;
Time frame: 1 time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 37857147Dabi Y, Suisse S, Marie Y, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Forlani S, Bouteiller D, Touboul C, Puchar A, Bendifallah S, Darai E. New class of RNA biomarker for endometriosis diagnosis: The potential of salivary piRNA expression. Eur J Obstet Gynecol Reprod Biol. 2023 Dec;291:88-95. doi: 10.1016/j.ejogrb.2023.10.015. Epub 2023 Oct 13.
- 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. This study is not recruiting at the moment.
EMILE DARAI, PROF study director
Centre Expert En Endométriose (C3E)
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 and Endometriosis Fertility, run by Groupe expert en endometriose-6 centre expert en endometriose 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 7 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SOFIANE BENDIFALLAH, MD PHD (0156015410, sofiane.bendifallah@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the evolution of miRNA expression (blood and salivary) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728152, which also lists 1 linked publication.
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 28 Jan 2021.