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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 (ENDETECT)

28 octobre 2026 mis à jour par: University Hospital, Lille

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Endométriose

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Celine CLAIRET-LESPINASSE
Numéro de téléphone: +33 3204441145
E-mail: celine.clairet@chu-lille.fr

Sauvegarde des contacts de l'étude

Nom: DRS. Promotion
Numéro de téléphone: +33 3204441145
E-mail: drs.promotion@chu-lille.fr

Lieux d'étude

France
- - Lille, France
    - CHU de Lille
    - Contact:
      
      Celine CLAIRET-LESPINASSE
      
      Numéro de téléphone: +33320444145
      
      E-mail: celine.clairet@chu-lille.fr
    - Contact:
      
      Chrydtele RUBOD DIT GUILLET, Pr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 43 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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:

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: CASE_ONLY
Perspectives temporelles: PROSPECTIVE

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
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. Délai: 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.	1 month + 3 weeks

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
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. Délai: 6 months + 3 weeks	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.	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 Délai: 6 months + 3 weeks	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.	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. Délai: 6 months + 3 weeks	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.	6 months + 3 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Lille

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 juin 2028

Dates d'inscription aux études

Première soumission

14 octobre 2026

Première soumission répondant aux critères de contrôle qualité

28 octobre 2026

Première publication (Réel)

4 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)