Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 4:18 PM
Study NCT ID:
NCT05244668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2022-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Validation of the Salivary miRNA Signature of Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At least a 90% Sensitivity (True Positive Rate) of Endometriosis diagnotic confirmation using a miRNA signature', 'timeFrame': 'Through the end of study inclusions, an average of 1 year', 'description': 'External validation of the salivary signature of endometriosis miRNAs'}, {'measure': 'At least a 90% Specificity (True Negative Rate) of Endometriosis diagnotic confirmation using a miRNA signature', 'timeFrame': 'Through the end of study inclusions, an average of 1 year', 'description': 'External validation of the salivary signature of endometriosis miRNAs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['miRNA', 'MAP', 'machine learning algorithms'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '41147827', 'type': 'DERIVED', 'citation': 'Bendifallah S, Roman H, Suisse S, Spiers A, Petit E, Delbos L, Dabi Y, Touboul C, Dennis T, Merlot B, Sauvanet E, Fauvet R, Jamard E, Clotilde H, Morgane P, Fedida B, Nyangoh K, Lavoue V, Roger CM, Lucas N, Darnaud T, Boudy AS, Genre L, Leguevaque P, Akldios C, Benjoar M, Chantalat E, Tanguy Le Gac Y, Poilblanc M, Rousset P, Fernandez H, Golfier F, Descamps P. Validation of a Saliva Micro-RNA Signature for Endometriosis. NEJM Evid. 2025 Nov;4(11):EVIDoa2400195. doi: 10.1056/EVIDoa2400195. Epub 2025 Oct 28.'}, {'pmid': '38320163', 'type': 'DERIVED', 'citation': 'Bendifallah S, Dabi Y, Suisse S, Delbos L, Spiers A, Poilblanc M, Golfier F, Jornea L, Bouteiller D, Fernandez H, Madar A, Petit E, Perotte F, Fauvet R, Benjoar M, Akladios C, Lavoue V, Darnaud T, Merlot B, Roman H, Touboul C, Descamps P. Validation of a Salivary miRNA Signature of Endometriosis - Interim Data. NEJM Evid. 2023 Jul;2(7):EVIDoa2200282. doi: 10.1056/EVIDoa2200282. Epub 2023 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'ENDOmiARN Salive Test is a multicentre external validation study of a salivary signature of endometriosis carried out in France in Obstetrics and Reproductive Medicine departments, in order to evaluate its performance and discuss its use in clinical practice. The clinical application is to significantly reduce the time to diagnosis and improve the care pathway for endometriosis.\n\nThe study population is made up of women aged 18 to 43 years with formally diagnosed endometriosis or suspected endometriosis who are already receiving either medical (MAP) or surgical treatment as part of their routine care.\n\nThe patients concerned by the study are managed without any change in the care pathway, nor any change in the therapeutic indications, nor any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the HAS recommendations.\n\nIn this study, the management and follow-up of patients :\n\n* 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,\n* Are not modified in comparison with the usual follow-up, except for the performance of :\n\n * Collection of saliva\n * Electronic collection of the answers to the questionnaires completed by the patient'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is made up of women aged 18 to 43 years with a formal diagnosis of endometriosis or suspected endometriosis.\n\nThe patients concerned by the study are already receiving either medical (MAP) or surgical care in a department of Obstetrics and Reproductive Medicine.\n\nAll these patients already benefit from validation of therapeutic indications in a multidisciplinary consultation meeting (medical-surgical or fertility RCP).\n\nThe patients concerned by the study are managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 18 and 43 years,\n* Patient having dated and signed the consent form,\n* Patient affiliated to the French health system,\n* Patient with pelvic MRI and/or pelvic ultrasound,\n* Patient from one of the 3 study populations:\n\n * Patient with a formal endometriosis diagnosed by clinical examination and imaging AND an indication for specialised endometriosis follow-up or medically assisted procreation (MAP) or surgery validated by RCP (in routine care);\n * Patient with suspected endometriosis for whom the diagnosis is the source of a discrepancy between clinical and radiological data AND a surgical indication validated by RCP (in routine care);\n * Patient with a gynaecological indication for surgery of the small pelvis by laparoscopy or laparoscopy validated in RCP (in routine care) AND symptoms suggestive of endometriosis (dysmenorrhoea, ....)(1).\n\nExclusion Criteria:\n\n* Patient with recurrence of deep endometriosis (excluding endometrioma),\n* Patient with endometriosis of the torus and/or utero-sacral ligaments without indication for surgery,\n* Patient with parietal endometriosis alone without indication for surgery,\n* Patient with adenomyosis alone on imaging without indication for surgery,\n* Patient with gynaecological infection requiring surgical management,\n* Pregnant patient,\n* Patient infected with the human immunodeficiency virus (HIV),\n* Patient with significant difficulties in reading or writing the French language,\n* Patient with a personal history of cancer,\n* Patient unable to comply with study and/or follow-up procedures,\n* Patient who has objected to the collection of her data.\n* Patient participating in another clinical research study.'}, 'identificationModule': {'nctId': 'NCT05244668', 'briefTitle': 'Multicenter Validation of the Salivary miRNA Signature of Endometriosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZIWIG'}, 'officialTitle': 'Multicenter Validation of the Salivary miRNA Signature of Endometriosis - The ENDOmiARN Salive Test Study', 'orgStudyIdInfo': {'id': 'FR-21-001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Québec', 'country': 'Canada', 'facility': 'CHU Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '67200', 'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'CHU Strasbourg - Hôpital Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'Clinique Tivoli', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Haute Garonne', 'country': 'France', 'facility': 'CHU Toulouse - Hôpital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31300', 'city': 'Toulouse', 'state': 'Haute-Garonne', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '35000', 'city': 'Rennes', 'state': 'Ille Et Vilaine', 'country': 'France', 'facility': 'Clinique La Sagesse', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '69002', 'city': 'Lyon', 'state': 'Rhône', 'country': 'France', 'facility': 'Cabinet de Gynécologie Médicale', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '76230', 'city': 'Bois-Guillaume', 'state': 'Seine-Maritime', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'state': 'Val De Marne', 'country': 'France', 'facility': 'Hôpital BICETRE', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '78310', 'city': 'Maurepas', 'state': 'Yvelines', 'country': 'France', 'facility': 'Centre médical des Pyramides', 'geoPoint': {'lat': 48.76486, 'lon': 1.92923}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '20600', 'city': 'Bastia', 'country': 'France', 'facility': 'CH Bastia', 'geoPoint': {'lat': 42.70219, 'lon': 9.45123}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'HCL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Saint Josef', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': "Centre d'imagerie Manin Crimée", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Tenons', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZIWIG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Monitoring Force Group', 'class': 'INDUSTRY'}, {'name': 'iGenSeq', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}