Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-03 @ 11:15 AM
Study NCT ID:
NCT06864494
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055356', 'term': 'Endometrial Ablation Techniques'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Vaginal swabs, endometrial ablation samples, urine, blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of L-PGDS in vaginal swabs between groups', 'timeFrame': 'Day 0', 'description': 'Assessed with immunoenzymatic ELISA (µg/ml)'}, {'measure': 'Concentration of L-PGDS in endometrial ablation sample in Adenomyosis - and + groups', 'timeFrame': 'Day 0', 'description': 'Assessed with immunoenzymatic ELISA (µg/ml) Day 0'}], 'secondaryOutcomes': [{'measure': 'Concentration of L-PGDS in blood between groups', 'timeFrame': 'Day 0', 'description': 'Assessed with immunoenzymatic ELISA (µg/ml) Day 0'}, {'measure': 'Concentration of L-PGDS in blood between groups', 'timeFrame': '7 weeks (range 6 to 8 weeks)', 'description': 'Assessed with immunoenzymatic ELISA (µg/ml) Day 0'}, {'measure': 'Concentration of L-PGDS in urine between groups', 'timeFrame': 'Day 0', 'description': 'Assessed with immunoenzymatic ELISA (µg/ml) Day 0'}, {'measure': 'Concentration of L-PGDS in urine between groups', 'timeFrame': '7 weeks (range 6 to 8 weeks)', 'description': 'Assessed with immunoenzymatic ELISA (µg/ml) Day 0'}, {'measure': 'Adenomyosis severity grade', 'timeFrame': 'Day 0', 'description': 'Measured by MRI. Severity grade: minimal (\\<25%), moderate (25-50%) or severe (\\>50%) uterine involvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lipocalin-Type Prostaglandin D2 Synthase'], 'conditions': ['Adenomyosis', 'Endometriosis']}, 'descriptionModule': {'briefSummary': "Prostaglandin D2 (PGD2) has anti-inflammatory activity, particularly via Lipocalin type-prostaglandin (L-PGDS). L-PGDS has been studied in pathologies such as sleep apnea, rheumatoid arthritis, asthma and allergic phenomena, but never in adenomyosis. Adenomyosis is a estrogen-dependent multifactorial pathology whose pathophysiology is still poorly defined. This hyperestrogenism causes chronic inflammation, particularly via the activation of the prostaglandin H2 (PGH2) signaling pathway. This would lead to the excess production of prostaglandins E2 (PGE2) and F2a (PGF2a) and the decrease of PGD2 and therefore of L-PGDS, leading to the proliferation of endometrial cells in the myometrium by the epithelial-mesenchymal transition via aromatase. A preliminary study comparing the expression of L-PGDS found a significant decrease in L-PGDS in the uterus of women with adenomyosis lesions versus healthy controls. However, during this study, some information was not collected, including the patients' symptoms, preoperative radiological data and surgical indication. The study authors hypothesize that L-PGDS could be a potential tissue and circulating diagnostic marker of adenomyosis in its early stages. L-PGDS appears to be a good candidate to aid in the diagnosis of adenomyosis via a minimally invasive assay for patients (blood or urine)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Multiparous, non-menopausal patients aged between 40 and 55 consulting the gynecology-obstetrics department of the CHU de Nîmes for menometrorrhagia and/or pelvic pain and having an indication for total inter-ovarian hysterectomy plus healthy controls aged between 18 and 43, nulliparous, without uterine pathologies treated at the Nîmes University Hospital's assisted reproduction center for male or idiopathic infertility.", 'eligibilityCriteria': 'Inclusion Criteria:\n\nCommon inclusion criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nAdenomyosis + group:\n\n* Female.\n* Aged 40 (≥) to 55 (≤) years.\n* Multiparous.\n* Non-menopausal.\n* Having an indication for a total inter-ovarian hysterectomy (excluding oncology).\n* Suffering from adenomyosis.\n\nAdenomyosis - group:\n\n* Female.\n* Aged 40 (≥) to 55 (≤) years.\n* Multiparous.\n* Non-menopausal.\n* Having an indication for a total inter-ovarian hysterectomy (excluding oncology).\n* Suffering from a functional pathology other than adenomyosis.\n\nControl Group:\n\n* Female.\n* Aged 18 (≥) to 43 (≤) years.\n* Nulliparous.\n* Asymptomatic: absence of menometrorrhagia and pelvic pain.\n* Support at the medically assisted procreation (MAP) center of the Nîmes University Hospital for male or idiopathic infertility.\n* Indication to perform an endovaginal ultrasound as part of MAP management.\n* Absence of uterine pathology visualized on endovaginal ultrasound.\n\nExclusion Criteria:\n\n* History of autoinflammatory or autoimmune disease.\n* History of atopic or asthmatic conditions.\n* History of sleep apnea syndrome.\n* Chronic or acute renal failure.\n* Liver failure\n* History of active neoplasia or cancer.\n* Presence of a functional-looking ovarian cyst on imaging (endovaginal ultrasound and/or pelvic MRI).\n* Taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or aspirin in the 15 days prior to L-PGDS concentration measurement\n* Undergoing estrogen-progestin hormonal contraception.\n\nAdenomyosis groups:\n\n\\- Contraindication to MRI.\n\nControl Group:\n\n\\- Endovaginal ultrasound refused by the patient.'}, 'identificationModule': {'nctId': 'NCT06864494', 'acronym': 'ADENO-L', 'briefTitle': 'Determination of Lipocalin Type-prostaglandin (L-PGDS) in Blood, Urine, Vaginal Samples and Endometrial Ablation by Enzyme-linked Immunosorbent Assay', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'L-PGDS (Lipocalin Type- Prostaglandin) Quantification in Genital, Blood and Urine Samples From Adenomyosis Patients Compared to 2 Control Groups.', 'orgStudyIdInfo': {'id': 'NIMAO/2024-1/SH01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with adenomyosis (Adenomyosis +)', 'interventionNames': ['Procedure: Endometrial ablation']}, {'label': 'Patients with an endometrial pathology other than adenomyosis (Adenomyosis -)', 'interventionNames': ['Procedure: Endometrial ablation']}, {'label': 'Patients without uterine pathology (control)'}], 'interventions': [{'name': 'Endometrial ablation', 'type': 'PROCEDURE', 'description': 'Performed using a transfer catheter (used for embryo transfers) positioned at the level of the internal cervical orifice in the uterine cavity. Five ml of saline will be injected and collected in a dry tube', 'armGroupLabels': ['Patients with adenomyosis (Adenomyosis +)', 'Patients with an endometrial pathology other than adenomyosis (Adenomyosis -)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anissa Megzari', 'role': 'CONTACT', 'email': 'drc@chu-nimes.fr', 'phone': '04.66.68.42.36'}, {'name': 'Stéphanie HUBERLANT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pascal PHILIBERT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Stéphanie HUBERLANT', 'role': 'CONTACT', 'email': 'stephanie.huberlant@chu-nimes.fr', 'phone': '04.66.68.32.20'}], 'overallOfficials': [{'name': 'Stéphanie HUBERLANT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}