EndometriosisADOmiARNNCT05928442
Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent
An observational study of Endometriosis, run by ZIWIG at 13 sites in 3 countries.
Trial summary
ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium. Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- in vitro diagnostic medical device and Completion of a self-questionnaire
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 13 Jun 2023to Nov 2024
- 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 10 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population made up of 3 differents adolescents populations: * "Endometriosis" patients: diagnosis confirmed by imaging; endometriosis formally diagnosed on clinical or imaging examination (ovarian endometriosis and/or severe deep endometriosis with vaginal, lateral or colorectal involvement) * "Discordants" patients: surgical confirmation; suspected endometriosis with discordant clinical and radiological data requiring surgical care (exploratory coelioscopy) for diagnosis in routine care, based on national recommendations and after validation by in RCP * "Sugery" patients: Surgical procedure motivated by a reason other than endometriosis: adolescents with another pelvic pathology requiring a planned surgical procedure, whether or not related to suspected endometriosis (ovarian cyst, uterine malformation) and with evocative symptoms of endometriosis.
Who may be able to join
- Patient aged between 10 and 19 years,
- Patient over 18 or legal representatives of patient under 18 who has dated and signed the consent form,
- Patient with pelvic MRI available and conduct within 12 months prior to inclusion,
- Patient from one of the 3 study populations:
- A formal endometriosis diagnosed by clinical examination and imaging or
- With prescription for coelioscopy because of a discrepancy between clinical and radiological findings or
- A surgical indication for a pathology of the small pelvis other than endometriosis, in adolescents with suspected endometriosis faced with symptoms suggestive (dysmenorrhea, chronic or cyclic pelvic pain, urinary disorders cycle-dependent)
- Patient affiliated to the healthcare system.
Who cannot join
- Known pregnancy in progress,
- Known infection with the human immunodeficiency virus (HIV),
- Personal history of cancer,
- Adolescent subject to a protective measure or placed adolescent,
- Adolescent or her legal representatives presenting important difficulties in reading French language,
- Patient or her legal representatives who have objected to the collection of her data,
- Patient participating in an interventional study with drug or medical device or in the exclusion period of an interventional study
- Patient who has participated or is participating in another study evaluating miRNA in endometriosis.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
France11 sites, 11 recruiting
- Recruiting
Centre chirurgical L'Avancée
Aix-en-Provence, 13090
Christine Lévêque, Dr
- Recruiting
CHU Angers
Angers, 49033
Philippe Descamps, Pr, phdescamps@chu-angers.fr
- Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Horace Roman, Pr
- Recruiting
CHU Caen
Caen, 14033
Raffaèle Fauvet, Pr
- Recruiting
AP-HM Hôpital de la Conception
Marseille, 13005
Lise Amart, Dr
- Recruiting
CHU Caremeau
Nîmes, 30029
Lucie Allègre, Dr
- Recruiting
Hôpital Tenon
Paris, 75020
Yohann Dabi, MD, yohann.dabi@aphp.fr
- Recruiting
APHP, Hôpital Cochin Port Royal
Paris
Pietro Santulli, Pr
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69310
François Golfier, Pr, françois.golfier@chu-lyon.fr
- Recruiting
CHU Rennes
Rennes, 35000
Krystel Nyangoh Timoh, Dr
- Recruiting
CHU Rouen
Rouen
Clotilde Hennetier, MD
Belgium1 site, 1 recruiting
- Recruiting
Hôpital de la Citadelle
Liège
Michelle Nisole, Pr
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsklinik für Frauenheilkunde, Inselspital Bern
Bern
Michael Mueller, Pr
About this study
Official title: Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent - The ADOmiARN Study
ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium.
The main objective is to confirm the interest of the in vitro diagnostic medical device (EndoTest®) in adolescents with suspected endometriosis.
Read more
The study population is made up of females aged 10 to 19 years with formally diagnosed endometriosis or suspected endometriosis.
The patients concerned by the study are managed without any change in the care pathway, no any change in the therapeutic indications, no any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the national guidelines.
In this study, the management and follow-up of patients :
- Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
- Are not modified in comparison with the usual follow-up, except for the performance of :
- Collection of saliva
- Completion of a self-questionnaire on symptom and quality-of-life.
- Conditions
- Endometriosis
- Being tested
- in vitro diagnostic medical device, Completion of a self-questionnaire
- Keywords
- miRNA, RNA, Machine learning algorithms, Adolescents
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro diagnostic medical deviceDevice
Collection of 2 saliva samples at inclusion.
Completion of a self-questionnaireBehavioural
Completion of a self-questionnaire on symptom and quality-of-life at inclusion.
in vitro diagnostic medical deviceDevice
Collection of 1 saliva sample at the follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| "Endometriosis" patients | Patient with a formal endometriosis diagnosed by clinical examination and imaging.
At least 20 patients Receives: Device: in vitro diagnostic medical device; Behavioral: Completion of a self-questionnaire | |
| "Discordants" patients | Patient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical examination and imaging data, AND a surgical indication.
At least 20 patients Receives: Device: in vitro diagnostic medical device; Behavioral: Completion of a self-questionnaire | |
| "Surgery" patients | Patient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis.
At least 20 patients Receives: Device: in vitro diagnostic medical device; Behavioral: Completion of a self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative).
Confirm the interest of EndoTest® in adolescents with suspected endometriosis
Measured: Through the end of study inclusions, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start13 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZIWIG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group, iGenSeq
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928442
- Sponsor's protocol ID
- 2023-02
- Acronym
- ADOmiARN
- Status last verified
- Apr 2024
- First submitted
- 23 Jun 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent - The ADOmiARN Study
- ClinicalTrials.gov ID
- NCT05928442
- Acronym / sponsor ID
- ADOmiARN / 2023-02
- Conditions
- Endometriosis
- Keywords
- miRNA, RNA, Machine learning algorithms, Adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group, iGenSeq
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium.
The main objective is to confirm the interest of the in vitro diagnostic medical device (EndoTest®) in adolescents with suspected endometriosis.
The study population is made up of females aged 10 to 19 years with formally diagnosed endometriosis or suspected endometriosis.
The patients concerned by the study are managed without any change in the care pathway, no any change in the therapeutic indications, no any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the national guidelines.
In this study, the management and follow-up of patients :
- Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
- Are not modified in comparison with the usual follow-up, except for the performance of :
- Collection of saliva
- Completion of a self-questionnaire on symptom and quality-of-life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Endometriosis" patients | – | Device: in vitro diagnostic medical device, Behavioral: Completion of a self-questionnairePatient with a formal endometriosis diagnosed by clinical examination and imaging. At least 20 patients |
| "Discordants" patients | – | Device: in vitro diagnostic medical device, Behavioral: Completion of a self-questionnairePatient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical examination and imaging data, AND a surgical indication. At least 20 patients |
| "Surgery" patients | – | Device: in vitro diagnostic medical device, Behavioral: Completion of a self-questionnairePatient with a gynaecological indication for surgery of the small pelvis AND symptoms suggestive of endometriosis. At least 20 patients |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population made up of 3 differents adolescents populations: * "Endometriosis" patients: diagnosis confirmed by imaging; endometriosis formally diagnosed on clinical or imaging examination (ovarian endometriosis and/or severe deep endometriosis with vaginal, lateral or colorectal involvement) * "Discordants" patients: surgical confirmation; suspected endometriosis with discordant clinical and radiological data requiring surgical care (exploratory coelioscopy) for diagnosis in routine care, based on national recommendations and after validation by in RCP * "Sugery" patients: Surgical procedure motivated by a reason other than endometriosis: adolescents with another pelvic pathology requiring a planned surgical procedure, whether or not related to suspected endometriosis (ovarian cyst, uterine malformation) and with evocative symptoms of endometriosis.
Key inclusion criteria (8 listed)
- Patient aged between 10 and 19 years,
- Patient over 18 or legal representatives of patient under 18 who has dated and signed the consent form,
- Patient with pelvic MRI available and conduct within 12 months prior to inclusion,
- Patient from one of the 3 study populations:
- Patient affiliated to the healthcare system.
Key exclusion criteria (8 listed)
- Known pregnancy in progress,
- Known infection with the human immunodeficiency virus (HIV),
- Personal history of cancer,
- Adolescent subject to a protective measure or placed adolescent,
- Adolescent or her legal representatives presenting important difficulties in reading French language,
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 |
|---|---|---|
| in vitro diagnostic medical deviceCollection of 2 saliva samples at inclusion. | Device | "Discordants" patients, "Endometriosis" patients, "Surgery" patients |
| Completion of a self-questionnaireCompletion of a self-questionnaire on symptom and quality-of-life at inclusion. | Behavioural | "Discordants" patients, "Endometriosis" patients, "Surgery" patients |
| in vitro diagnostic medical deviceCollection of 1 saliva sample at the follow-up visit. | Device | "Discordants" patients, "Surgery" patients |
Primary outcome
Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative).
Time frame: Through the end of study inclusions, an average of 1 year
Confirm the interest of EndoTest® in adolescents with suspected endometriosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by ZIWIG at 13 sites in 3 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 8 inclusion and 8 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium, Switzerland. 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 Philippe Descamps, Pr (02 41 35 48 99 ext. +33, phdescamps@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adolescents with a negative EndoTest® despite a validated diagnosis of endometriosis by coelioscopy or other surgical movement (false negative). (time frame: Through the end of study inclusions, an average of 1 year). 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 10 Apr 2024.