Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-22 @ 2:11 AM
Study NCT ID:
NCT06470594
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil to lymphocyte ratio', 'timeFrame': 'Measured before and after (24 to 72 hours) surgery'}], 'secondaryOutcomes': [{'measure': 'Platelet to lymphocyte ratio', 'timeFrame': 'Measured before and after (24 to 72 hours) surgery'}, {'measure': 'Lymphocyte to monocyte ratio', 'timeFrame': 'Measured before and after (24 to 72 hours) surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring.\n\nParticipants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with chronic pelvic pain and/or infertility with a sonographic or MRI ascertained suspicion of endometriosis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 45 years.\n* Postoperative follow-up of at least 12 months;\n* Signature of informed consent regarding laparoscopic surgical treatment.\n* Signature of informed consent to the processing of personal data duly documented by medical records.\n\nExclusion Criteria:\n\n* Failure to sign informed consent for laparoscopic surgical treatment\n* Histologic diagnosis of borderline tumor and/or ovarian carcinoma and/or mucinous cystadenoma and/or germ cell tumor or other malignancy of the genital tract\n* postoperative follow-up of less than 12 months;\n* documented history of inflammatory, rheumatologic, or immunologic disease; and\n* failure to provide informed consent for personal data processing.'}, 'identificationModule': {'nctId': 'NCT06470594', 'acronym': 'ESPRIMO-CCR', 'briefTitle': 'Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes', 'orgStudyIdInfo': {'id': '0016489/i'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Superficial Endometriosis', 'description': 'Laparoscopic excision of superficial (peritoneal) endometriotic implants'}, {'label': 'Ovarian Endometriosis', 'description': 'Laparoscopic excision of ovarian endometrioma/s'}, {'label': 'Deep Infiltrating Endometriosis (DIE)', 'description': 'Laparoscopic excision of DIE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gaetano Riemma', 'role': 'CONTACT'}, {'name': 'Pasquale De Franciscis, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Gaetano Riemma, MD', 'role': 'CONTACT', 'email': 'gaetano.riemma@unicampania.it', 'phone': '0038 0815665599'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gaetano Riemma', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}