Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT06245512
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Menstrual blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic and prognostic score', 'timeFrame': '3 years and 8 months', 'description': 'Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis and for their prognostic potential in the context of response to surgical treatment (significant quantitative difference between before and after surgery). Biomarkers that are both significantly quantitatively different between women with and without endometriosis and before versus after surgery will constitute the final set and this set will be measured by targeted approach in all the participants. This score, associated or not with clinical characteristics (such as for example the intensity of pain, the association of different types of pain), will make it possible to differentiate women with and without endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic score', 'timeFrame': '3 years and 8 months', 'description': 'Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis.'}, {'measure': 'Prognostic candidate score', 'timeFrame': '3 years and 8 months', 'description': 'Score based on candidate biomarkers that will be selected for their significant quantitative differences between before and after surgery. This score will have to be validated in a bigger cohort in a subsequent clinical study to assess its specificity and sensitivity to differentiate women for who the surgery is effective from women for who the surgery is not or only partially effective, or women with a recurrence of the disease.'}, {'measure': 'Diagnostic score for a specific subtype of endometriosis', 'timeFrame': '3 years and 8 months', 'description': 'Score based on candidate biomarkers that will be selected for their quantitative differences between the patients with different subtypes of endometriosis. This score, associated or not with clinical characteristics (such as for example the intensity of pain, the association of different types of pain), will make it possible to differentiate women with a specific subtype of endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarker', 'diagnosis', 'prognosis'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to identify diagnostic and prognostic biomarkers for endometriosis using menstrual blood, an easily accessible yet overlooked biological fluid in women of reproductive age, affected or not by endometriosis\n\nThe main questions it aims to answer are:\n\n* are there relevant differences in the menstrual blood of women affected by endometriosis compared to women without endometriosis?\n* do some of these differences disappear or lessen when the disease is treated by surgery? Participants will answer questions relevant to endometriosis and provide menstrual blood 1 to 3 times (self-collected with a menstrual cup). A subgroup of participants affected by endometriosis that will undergo surgery for their regular care will provide menstrual blood before and after their surgery.\n\nResearchers will compare the menstrual blood of women with and without endometriosis, and before and after surgery to see if they can identify significant differences.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women 18-45 of age with periods', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all participants:\n\nWomen 18-45 of age who\n\n* Have their period\n* Have given their written consent\n* Have already used a menstrual cup as a method of hygienic protection\n* Residing or working in Ile de France (Paris Metropolitan area, France)\n\nFor participants with endometriosis:\n\n* diagnosis of endometriosis established by surgery or imaging (ultrasound and/or MRI)\n* presence of one or more painful symptoms \\> 3 on a visual scale (dysmenorrhea and/or dyspareunia and/or chronic pelvic pain) and/or infertility\n* for the surgery subgroup: planned surgery in the next 3 months\n\nFor participants without endometriosis:\n\n* painful symptoms \\< or equal to 3 on a visual scale (for dysmenorrhea and dyspareunia and chronic pelvic pain),\n* absence of intense period pain in adolescence (leading to taking pills to control this pain and/or peri-menstrual school absenteeism)\n\nExclusion Criteria:\n\nFor all participants:\n\n* Autoimmune diseases\n* Chronic diseases other than endometriosis (diabetes, hypertension)\n* A person who is the subject of a judicial safeguard measure (by declaration)\n* Infectious diseases (HIV, HBV, if known)\n* History of menstrual toxic shock syndrome\n\nFor patients with endometriosis:\n\n* endometriosis surgery within the last 3 months.'}, 'identificationModule': {'nctId': 'NCT06245512', 'acronym': 'MultiMENDo', 'briefTitle': 'Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "RECHERCHE DE MARQUEURS DIAGNOSTIQUES ET PRONOSTIQUES DE L'ENDOMETRIOSE DANS LE SANG DES REGLES CHEZ LES FEMMES EN AGE DE PROCREER", 'orgStudyIdInfo': {'id': 'C22-75'}, 'secondaryIdInfos': [{'id': '2023-A01857-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'With endometriosis', 'description': 'Women affected by endometriosis'}, {'label': 'Without endometriosis', 'description': 'Women without any clinical sign of endometriosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Ludivine Doridot', 'role': 'CONTACT', 'email': 'ludivine.doridot@inserm.fr', 'phone': '33(0)1 40 51 64 33'}], 'overallOfficials': [{'name': 'Louis Marcellin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}