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Not yet recruitingNCT07915765ENDETECTUpdated Nov 4, 2026

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 in Endometriosis, sponsored by University Hospital, Lille. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by University Hospital, Lille · Observational

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 43 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Endometriosis

Keywords

  • Endometriosis
  • Endotest
  • diagnosis
  • pain catastrophizing
  • quality of life
  • anxiety
  • depression
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In context

Endometriosis

929 studies on the registry are indexed under Endometriosis; 267 are open to participants now.

This study's planned enrollment of 50 is below the median of 122 across 356 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for suspected endometriosis, with negative imaging findings and for whom an endotest has been indicated.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month + 3 weeks

Secondary outcomes

  1. 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.

    Time frame: 6 months + 3 weeks

  2. 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.

    Time frame: 6 months + 3 weeks

  3. 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.

    Time frame: 6 months + 3 weeks

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.

Of 153 non-industry observational studies under Endometriosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 19 months is below that.

Counting every sponsor, half of 182 studies reached it within 30 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Nov 4, 2026
StartEst.
Nov 2026
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07915765
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Celine CLAIRET-LESPINASSE
Contact
celine.clairet@chu-lille.fr
+33 3204441145
DRS. Promotion
Contact
drs.promotion@chu-lille.fr
+33 3204441145

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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