EndometriosisENDETECTNCT07915765
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
An observational study of Endometriosis, run by University Hospital, Lille at 1 site in France.
Trial summary
This non-interventional study aims to assess the impact of an endometriosis diagnosis obtained through a salivary test (Ziwig Endotest®) on pain-related cognitions, quality of life, mood, and treatment adherence, comparingthese outcomes with those of individuals who underwent the same salivary test but received a… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Jun 2028
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients referred for suspected endometriosis, with negative imaging findings and for whom an endotest has been indicated.
Who may be able to join
- Patients eligible for an endotest as part of the innovation package at Jeanne de Flandre Hospital
- Patients between 18 to 43 years old
- Understand and can communicate in French
- Having received medical images that do not allow the diagnosis of endometriosis
- Presenting with symptoms suggestive of endometriosis
- Giving oral non-opposition to participe in the study
- Beneficiary of health insurance coverage
- Having normal visual and auditory acuity or corrected to normal levels
Who cannot join
- Minors, adults under guardianship, under judicial protection, and persons deprived of liberty
- Refusal to participate after receiving clear and fair information about the study
- Sensory, visual or auditory inability to participate in the study
- Personal history of neurological disorders or current neurological disorder
- Consumtion of toxic substances other than tobacco and alcohol.
- Personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, or trauma- and stress-related disorders
- Use of psychotropic medications
- Pregnant or breastfeeding women
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
CHU de Lille
Lille
Celine CLAIRET-LESPINASSE, +33320444145, celine.clairet@chu-lille.fr
Chrydtele RUBOD DIT GUILLET, Pr
About this study
This non-interventional study aims to assess the impact of an endometriosis diagnosis obtained through a salivary test (Ziwig Endotest®) on pain-related cognitions, quality of life, mood, and treatment adherence, comparingthese outcomes with those of individuals who underwent the same salivary test but received a negative result and were therefore not diagnosed with endometriosis.
Participation in this study will contribute to advancing research in the field of endometriosis diagnosis and multidisciplinary management by expanding current knowledge of diagnostic protocols and their impact on pain, quality of life, treatment adherence, and potential psychiatric comorbidities. The investigators hope to enhance understanding of endometriosis and pelvic pain symptomatology in order to develop new therapeutic strategies, including psychological interventions or integrated psychological care, that better address the needs and specific characteristics of patients whether or not they receive a diagnosis of endometriosis.
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Endotest, diagnosis, pain catastrophizing, quality of life, anxiety, depression
- Medical subject headings
- Endometriosis, Disease, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain catastrophizing 1 month after being informed of the results of the saliva test among patients diagnosed with endometriosis and among patients not diagnosed with endometriosis.
Change in the Pain Catastrophizing Scale score between baseline and 1 month after the announcement of the salivary test results.
Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points.
Measured: 1 month + 3 weeks
Secondary outcomes (3)
Changes 1 month after the consultation during which the results of the salivary test for pain catastrophizing were announced, based on the diagnosis of endometriosis.
Change from baseline to 1 month after the announcement of the salivary test results in the Pain Catastrophizing Scale score.
Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points.
Measured: 6 months + 3 weeks
Changes at 1 month and 6 months after the consultation during which the saliva test results were announced, based on whether endometriosis was diagnosed: • Quality of life • Anxiety and depressive symptoms • Treatment adherence
Change from baseline to 1 month after the results were announced, and from baseline to 6 months after the results were announced. Use:
- Endometriosis Health Profile-30 questionnaire (Quality-of-life score specific to women with endometriosis) - divided into several themes: general (focusing particularly on pain and psychological impacts), work, children, sexual relations, healthcare providers, treatment, and difficulties conceiving - 53 items rated on a scale of 1 to 5,
- World Health Organization Quality of Life (Quality of life score in the domains of "physical health," "psychological well-being," "social relationships," and "environment") - 26 items rated on a 5-point scale with a maximum total score of 130,
- Hospital Anxiety and Depression Scale questionnaire (Anxiety and depression score) - a two-part score consisting of 7 items each, rated on a 21-point scale,
- Medication Adherence Report Scale (Therapeutic compliance) - 10 items - score out of 10.
Measured: 6 months + 3 weeks
Changes at 6 months following the consultation during which the results of the salivary test for pain catastrophizing were reported, based on the diagnosis of endometriosis.
To compare the change in pain catastrophizing at 6 months following the consultation disclosing the salivary test results, between patients diagnosed with endometriosis and those not diagnosed with endometriosis.
Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points.
Measured: 6 months + 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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 University Hospital, LilleThe 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915765
- Sponsor's protocol ID
- 2025_0266
- Acronym
- ENDETECT
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
- ClinicalTrials.gov ID
- NCT07915765
- Acronym / sponsor ID
- ENDETECT / 2025_0266
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Endotest, diagnosis, pain catastrophizing, quality of life, anxiety, depression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
This non-interventional study aims to assess the impact of an endometriosis diagnosis obtained through a salivary test (Ziwig Endotest®) on pain-related cognitions, quality of life, mood, and treatment adherence, comparingthese outcomes with those of individuals who underwent the same salivary test but received a negative result and were therefore not diagnosed with endometriosis.
Participation in this study will contribute to advancing research in the field of endometriosis diagnosis and multidisciplinary management by expanding current knowledge of diagnostic protocols and their impact on pain, quality of life, treatment adherence, and potential psychiatric comorbidities. The investigators hope to enhance understanding of endometriosis and pelvic pain symptomatology in order to develop new therapeutic strategies, including psychological interventions or integrated psychological care, that better address the needs and specific characteristics of patients whether or not they receive a diagnosis of endometriosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients referred for suspected endometriosis, with negative imaging findings and for whom an endotest has been indicated.
Key inclusion criteria (8 listed)
- Patients eligible for an endotest as part of the innovation package at Jeanne de Flandre Hospital
- Patients between 18 to 43 years old
- Understand and can communicate in French
- Having received medical images that do not allow the diagnosis of endometriosis
- Presenting with symptoms suggestive of endometriosis
Key exclusion criteria (8 listed)
- Minors, adults under guardianship, under judicial protection, and persons deprived of liberty
- Refusal to participate after receiving clear and fair information about the study
- Sensory, visual or auditory inability to participate in the study
- Personal history of neurological disorders or current neurological disorder
- Consumtion of toxic substances other than tobacco and alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in pain catastrophizing 1 month after being informed of the results of the saliva test among patients diagnosed with endometriosis and among patients not diagnosed with endometriosis.
Time frame: 1 month + 3 weeks
Change in the Pain Catastrophizing Scale score between baseline and 1 month after the announcement of the salivary test results. Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points.
3 secondary outcomes
Changes 1 month after the consultation during which the results of the salivary test for pain catastrophizing were announced, based on the diagnosis of endometriosis.
Time frame: 6 months + 3 weeks
Changes at 1 month and 6 months after the consultation during which the saliva test results were announced, based on whether endometriosis was diagnosed: • Quality of life • Anxiety and depressive symptoms • Treatment adherence
Time frame: 6 months + 3 weeks
Changes at 6 months following the consultation during which the results of the salivary test for pain catastrophizing were reported, based on the diagnosis of endometriosis.
Time frame: 6 months + 3 weeks
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 4 Nov 2026.
- 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.
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 University Hospital, Lille 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 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: opening soon, as of the sponsor's last update on 4 Nov 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 Celine CLAIRET-LESPINASSE (+33 3204441145, celine.clairet@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain catastrophizing 1 month after being informed of the results of the saliva test among patients diagnosed with endometriosis and among patients not diagnosed with endometriosis. (time frame: 1 month + 3 weeks). 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 4 Nov 2026.