Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT06584760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-05
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Impact of Chronic Pelvic Pain on 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_WITH_DNA', 'description': 'Preoperative venous blood from patients with endometriosis and pathological tissue of endometriosis removed during surgery were collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic pelvic pain', 'timeFrame': 'Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)', 'description': 'Using Simplified McGill Pain Questionnaire (SF-MPQ) for scoring'}, {'measure': 'In vitro detection results', 'timeFrame': 'Venous blood within 3 days before surgery; Endometriosis sample excised during surgery', 'description': 'The results of immunohistochemistry, ELISA, and transcriptome sequencing of preoperative venous blood and endometrial tissue excised during surgery in patients with endometriosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic pelvic pain', 'Endometriosis'], 'conditions': ['Chronic Pelvic Pain', 'Endometriosis']}, 'descriptionModule': {'briefSummary': 'Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.\n\nExplore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.', 'detailedDescription': 'Conduct preoperative and postoperative endometriosis related questionnaire surveys on patients, such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Follow up will be conducted 1-2 months after surgery. Preoperative venous blood from patients with endometriosis and pathological tissue of endometriosis removed during surgery were collected for in vitro testing using immunohistochemistry, ELISA, transcriptome sequencing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 50 years old;\n* Endometriosis diagnosed through previous surgery (confirmed solely by visual or histopathological examination), endometriosis discovered through imaging examination, deep infiltrating nodules discovered through palpation or imaging examination, and clinically suspected endometriosis;\n* No history of migraine or tension headaches;\n* No history of mental illness (such as restless leg syndrome, chronic fatigue syndrome, fibromyalgia, anxiety or panic attacks, depression).\n\nExclusion Criteria:\n\n* Postmenopausal state (spontaneous or surgical);\n* Previous hysterectomy and/or bilateral salpingo oophorectomy (prior to preoperative visit);\n* The patient or authorizer refuses.'}, 'identificationModule': {'nctId': 'NCT06584760', 'briefTitle': 'Research on the Impact of Chronic Pelvic Pain on Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}, 'officialTitle': 'Research on the Impact of Chronic Pelvic Pain on Endometriosis', 'orgStudyIdInfo': {'id': 'KY-2024-152'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometriosis group', 'description': 'Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '322000', 'city': 'Yiwu', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Jiannan He', 'role': 'CONTACT', 'email': '8018038@zju.edu.cn', 'phone': '+86 13615893226'}], 'facility': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine, No. N1, Shopping Mall Avenue', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Jiannan He', 'role': 'CONTACT', 'email': '8018038@zju.edu.cn', 'phone': '13615893226'}], 'overallOfficials': [{'name': 'Jiannan He', 'role': 'STUDY_CHAIR', 'affiliation': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}