Endometriosis (Diagnosis)NCT03376451
EndoSearch : Endometriosis Biomarkers
A study testing Assessment of endometrium and blood biomarkers for endometriosis diagnosis in people with Endometriosis (Diagnosis) and Blood Biomarkers, run by Dr Afchine Fazel at 1 site in France.
Trial summary
EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis (Diagnosis), Blood Biomarkers, Endometrium Biomarkers
- What is being tested?
- Assessment of endometrium and blood biomarkers for endometriosis diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman, from 18 to 45
- Patients with endometriosis suspicion, associated adenomyosis is accepted
- Freely signature of the consent form
- Patient needs laparoscopy for endometriosis purpose (first intervention or recurrence) regardless of the endometriosis type (superficial, ovarian or deep)
- Possibility of follow up during 2 years.
- Woman 18 to 45
- Freely signature of the consent form
- Patient needs laparoscopy for another indication than endometriosis, adenomyosis, uterine fibroma \& other fibroid pathologies (ex of surgeries: tubular sterilization, ovarian non-fibroid cyst, urinary incontinence requiring ureteral intervention).
Who cannot join
- Refusal or linguistic or psychic incapacity to sign informed consent
- No internet access or refusal to use new technologies
- Minor woman (under 18 years old)
- Pregnancy or breastfeeding
- Menopause
- Evidence of adenomyosis without endometriosis
Show all 16Show fewer
- All metabolic pathology, endocrine, chronical infectious or malignant.
- Endometriosis negative result at visual and histological examination by anatomopathologist of the clinical centre.
- Refusal or linguistic or psychic incapacity to sign informed consent
- No internet access or refusal to use new technologies
- Minor woman (under 18 years old)
- Pregnancy or breastfeeding
- Menopause
- Adenomyosis
- All metabolic pathology, endocrine, chronical infectious or malignant.
- Endometriosis positive result at visual and histological examination by anatomopathologist of the clinical centre.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Endodiag
Paris, 75014
Juliette Delhaye, engineer, +33(0)7 60 62 92 94, juliette.delhaye@endodiag.com
Helene Beny, engineer, +33(0)9 62 50 72 93, helene.beny@endodiag.com
About this study
Official title: Validation of Specific Biomarkers for the Diagnosis of Endometriosis
EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls).
EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.
Read the detailed description
Endometriosis is a very common gynecological disease affecting 10% of women of reproductive age. Main symptoms are chronic and severe pain in pelvis area and infertility in up to 40% of affected women. Currently, the only method to obtain a reliable diagnosis is the analysis of endometriotic lesions removed during surgery under general anaesthesia. There is a real need to diagnosis endometriosis non-invasively and quickly in order to improve patient management.
EndoSearch aims to analytically validate a cluster of endometrial and blood biomarkers identified in previous studies and specific for the endometriosis diagnosis and disease prognosis recurrence. During 2 years (follow up period) and 9 months (inclusion period), 15 clinical centers worldwide will recruit patients and collect biological samples and personal and clinical data from these patients. The biological samples will be processed at Endodiag labs, Paris, France though lab biotechnology techniques. Results will allow the assessment of sensibility and specificity (NPV and PPV) of the biomarker signature for endometriosis diagnosis and disease recurrence.
- Being tested
- Assessment of endometrium and blood biomarkers for endometriosis diagnosis
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of endometrium and blood biomarkers for endometriosis diagnosisOther
Biological samples will be collected from patients, sent to Endodiag, Paris, in France and be processed through IHC and molecular biology techniques to assess the ability of the identified biomarkers signature to diagnose and prognose endometriosis.
| Study group | Role | What they receive |
|---|---|---|
| Patients in EndoSearch | Other | EndoSearch will conduct on only one cohort divided in two groups : patients affected by endometriosis and patient unaffected (controls). All of these patients need a laparoscopic surgery for endometriosis indication (endometriosis group) or another indication which is not endometriosis (controls). However, nothing in the surgery or the patient medical care will be different between the two groups : patients will be treated exactly the same. Receives: Other: Assessment of endometrium and blood biomarkers for endometriosis diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility for endometriosis diagnosis (probability of detection)
Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.
Measured: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Specificity for endometriosis diagnosis
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis
Measured: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Secondary outcomes (2)
Sensibility for endometriosis recurrence prognostic (probability of detection)
Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis recurrence prognostic.
Measured: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)
Specificity for endometriosis recurrence prognostic
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis recurrence prognostic.
Measured: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis (Diagnosis)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- EndoSearch recruits two groups of patients : affected by endometriosis and unaffected (controls) but both of them need a surgery for different indication (endometriosis for patients and other for controls (i.e dermoid cyst).
- Masking
- None (open label)
- Enrolment
- 975 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Afchine Fazel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr Afchine Fazel, Endodiag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376451
- Sponsor's protocol ID
- 2017-A01445-48
- Status last verified
- May 2022
- First submitted
- 29 Nov 2017
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Specific Biomarkers for the Diagnosis of Endometriosis
- ClinicalTrials.gov ID
- NCT03376451
- Acronym / sponsor ID
- 2017-A01445-48
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 975 participants (estimated)
- Lead sponsor
- Dr Afchine FazelIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Dec 2017 (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.
EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls).
EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.
Detailed description
Endometriosis is a very common gynecological disease affecting 10% of women of reproductive age. Main symptoms are chronic and severe pain in pelvis area and infertility in up to 40% of affected women. Currently, the only method to obtain a reliable diagnosis is the analysis of endometriotic lesions removed during surgery under general anaesthesia. There is a real need to diagnosis endometriosis non-invasively and quickly in order to improve patient management.
EndoSearch aims to analytically validate a cluster of endometrial and blood biomarkers identified in previous studies and specific for the endometriosis diagnosis and disease prognosis recurrence. During 2 years (follow up period) and 9 months (inclusion period), 15 clinical centers worldwide will recruit patients and collect biological samples and personal and clinical data from these patients. The biological samples will be processed at Endodiag labs, Paris, France though lab biotechnology techniques. Results will allow the assessment of sensibility and specificity (NPV and PPV) of the biomarker signature for endometriosis diagnosis and disease recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- EndoSearch recruits two groups of patients : affected by endometriosis and unaffected (controls) but both of them need a surgery for different indication (endometriosis for patients and other for controls (i.e dermoid cyst).
| Arm | Type | Receives |
|---|---|---|
| Patients in EndoSearch | Other | Other: Assessment of endometrium and blood biomarkers for endometriosis diagnosisEndoSearch will conduct on only one cohort divided in two groups : patients affected by endometriosis and patient unaffected (controls). All of these patients need a laparoscopic surgery for endometriosis indication (endometriosis group) or another indication which is not endometriosis (controls). However, nothing in the surgery or the patient medical care will be different between the two groups : patients will be treated exactly the same. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Woman, from 18 to 45
- Patients with endometriosis suspicion, associated adenomyosis is accepted
- Freely signature of the consent form
- Patient needs laparoscopy for endometriosis purpose (first intervention or recurrence) regardless of the endometriosis type (superficial, ovarian or deep)
- Possibility of follow up during 2 years.
Key exclusion criteria (16 listed)
- Refusal or linguistic or psychic incapacity to sign informed consent
- No internet access or refusal to use new technologies
- Minor woman (under 18 years old)
- Pregnancy or breastfeeding
- Menopause
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 |
|---|---|---|
| Assessment of endometrium and blood biomarkers for endometriosis diagnosisBiological samples will be collected from patients, sent to Endodiag, Paris, in France and be processed through IHC and molecular biology techniques to assess the ability of the identified biomarkers signature to diagnose and prognose endometriosis. | Other | Patients in EndoSearch |
Primary outcome
Sensibility for endometriosis diagnosis (probability of detection)
Time frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.
Specificity for endometriosis diagnosis
Time frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis
2 secondary outcomes
Sensibility for endometriosis recurrence prognostic (probability of detection)
Time frame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)
Specificity for endometriosis recurrence prognostic
Time frame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of endometrium and blood biomarkers for endometriosis diagnosis in people with Endometriosis (Diagnosis) and Blood Biomarkers, run by Dr Afchine Fazel 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 8 inclusion and 16 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 12 May 2022. 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 Juliette Delhaye, engineer (+33(0)7 62 62 92 94, juliette.delhaye@endodiag.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility for endometriosis diagnosis (probability of detection) (time frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)). The study lists 2 primary outcomes in all. 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 12 May 2022.