Nctid:
NCT06234670
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007889", "term"=>"Leiomyoma"}, {"id"=>"D000047708", "term"=>"Myofibroma"}, {"id"=>"D000012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000009379", "term"=>"Neoplasms, Muscle Tissue"}, {"id"=>"D000018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009372", "term"=>"Neoplasms, Connective Tissue"}, {"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrence", "relevance"=>"HIGH"}, {"id"=>"M10901", "name"=>"Leiomyoma", "asFound"=>"Uterine Fibroids", "relevance"=>"HIGH"}, {"id"=>"M25846", "name"=>"Myofibroma", "asFound"=>"Uterine Fibroids", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12317", "name"=>"Neoplasms, Connective Tissue", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>3200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-25", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-28", "studyFirstSubmitDate"=>"2023-12-21", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC", "timeFrame"=>"through study completion, about June.2025", "description"=>"Complete the follow-up, and compare the actual recurrence population with the predicted recurrence population to judge the performance of the prediction model. Use the AUC (Area Under Curve)"}], "secondaryOutcomes"=>[{"measure"=>"Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis", "timeFrame"=>"about June.2024", "description"=>"To identify the risk factors of recurrent uterine fibroids. We identify the risk factors through statistic analysis. Statistical significance proves to be the symbol of identifycation of risk factors."}, {"measure"=>"The recurrence rate of uterine fibroids yearly", "timeFrame"=>"about Febrary.2024", "description"=>"To calculate the recurrence rate of uterine fibroids yearly"}, {"measure"=>"The fertility rate after myomectomy", "timeFrame"=>"about Febrary.2024", "description"=>"To research the fertility rate after myomectomy and evaluate the impact of the surgery."}, {"measure"=>"The quality of life after myomectomy will be assessed by UFS-QOL,(uterine fibroid symptom and health-related quality of life, UFS-QOL)", "timeFrame"=>"through study completion, about June.2025", "description"=>"To assess the quality of life after myomectomy, we use UFS-QOL.The UFS-QOL, the most popular self-administered instrument in assessing the whole spectrum of fibroid-related symptoms and health-related quality of life among patients with uterine fibroids, was designed in 2002s by James B et.al.\n\nConsisting of eight symptom items and twenty-nine health-related quality of life (HRQL) items of six subscales (concern, activities, energy/mood, control, self-consciousness, and sexual functioning), UFS-QOL is scored with a 5-point scale which demonstrates the patient' state of past 3 months. The final score (range, 0-100) is transformed based on a specific formula. Usually, a higher symptom severity score means more severe symptoms while a higher HRQL score indicates more perfect health"}, {"measure"=>"The degree of abdominal pain after myomectomy will be assessed by VAS（visual analogue scale, VAS）", "timeFrame"=>"through study completion, about June.2025", "description"=>"VAS is the most commonly used one-dimensional measure of pain intensity. The scale consists mainly of a 100 mm straight line with one end indicating \"completely painless\" and the other end indicating \"the most severe pain imaginable\" or \"extremely painful\", etc. Patients will be asked to mark the line at the appropriate location to represent the intensity of the pain they are experiencing at the time"}, {"measure"=>"The blood loss will be assessed by PBLAC (Pictorial Blood Loss Assessment Chart (PBLAC)", "timeFrame"=>"through study completion, about June.2025", "description"=>"The Pictorial Blood Loss Assessment Chart (PBLAC) proposed by Higham JM in 1990 is widely used internationally to evaluate menstrual flow. 1 Menstrual blood loss chart The menstrual blood loss chart is given different scores according to the different degrees of blood staining of each sanitary napkin: mild (1 point), the blood stained area \\< 1/3 of the whole sanitary napkin; Moderate (5 points): The blood stained area accounts for 1/3\\~3/5 of the whole sanitary napkin; Severe (20 points): The blood-stained area is basically the entire sanitary napkin."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Uterine Fibroid", "Recurrence", "Risk factor", "Prediction medel"], "conditions"=>["Uterine Fibroid", "Recurrence"]}, "descriptionModule"=>{"briefSummary"=>"To research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.", "detailedDescription"=>"Uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. With the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. However, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems.\n\nAccording to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. At the eighth year of myomectomy, the recurrence rate is as high as 84.4%. During the long-term follow-up, about one-third of patients eventually require reoperation.\n\nRecurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "genderBased"=>true, "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Female patients with uterine fibroids and accept myomectomy.", "genderDescription"=>"Female patients with uterine fibroids", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age:18-50 years\n2. Diagnosed with uterine fibroids （by ultrasound or pathology）\n3. Accept myomectomy.\n4. Complete clinical data.\n\nExclusion Criteria:\n\n1. Severe infectious disease\n2. Previous history of malignant tumors\n3. Incomplete clinical data.\n4. Pregnant"}, "identificationModule"=>{"nctId"=>"NCT06234670", "briefTitle"=>"Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids", "organization"=>{"class"=>"OTHER", "fullName"=>"Tongji Hospital"}, "officialTitle"=>"Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids", "orgStudyIdInfo"=>{"id"=>"V1.0"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients with uterine fibroids accepted myomectomy.", "description"=>"Complete the observation and follow-up, to identify the outcome （recur or not recur).", "interventionNames"=>["Other: No intervertion"]}], "interventions"=>[{"name"=>"No intervertion", "type"=>"OTHER", "description"=>"This study is a retrospective observational study without intervention.", "armGroupLabels"=>["Patients with uterine fibroids accepted myomectomy."]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"430030", "city"=>"Wuhan", "state"=>"None Selected", "country"=>"China", "contacts"=>[{"name"=>"shixuan Wang", "role"=>"CONTACT", "email"=>"shixuanwang@tjh.tjmu.edu.cn", "phone"=>"86-27-83663078"}], "facility"=>"Shixuan Wang", "geoPoint"=>{"lat"=>30.58333, "lon"=>114.26667}}], "centralContacts"=>[{"name"=>"shixuan Wang, Phd", "role"=>"CONTACT", "email"=>"shixuanwang@tjh.tjmu.edu.cn", "phone"=>"86-27-83663078"}, {"name"=>"Wenwen Wang, Phd", "role"=>"CONTACT", "email"=>"wenwenwang@hust.edu.cn", "phone"=>"86-27-83663078"}], "overallOfficials"=>[{"name"=>"Shixuan Wang, Phd", "role"=>"STUDY_CHAIR", "affiliation"=>"Huazhong University of Science and Technology"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Wenwen Wang", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Tongji Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Wenwen Wang", "investigatorAffiliation"=>"Tongji Hospital"}}}}
