Nctid:
NCT06234553
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000236", "term"=>"Adenoma"}, {"id"=>"D010911", "term"=>"Pituitary Neoplasms"}, {"id"=>"D010900", "term"=>"Pituitary Diseases"}], "ancestors"=>[{"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D007027", "term"=>"Hypothalamic Diseases"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D007029", "term"=>"Hypothalamic Neoplasms"}, {"id"=>"D015173", "term"=>"Supratentorial Neoplasms"}, {"id"=>"D001932", "term"=>"Brain Neoplasms"}, {"id"=>"D016543", "term"=>"Central Nervous System Neoplasms"}, {"id"=>"D009423", "term"=>"Nervous System Neoplasms"}], "browseLeaves"=>[{"id"=>"M3591", "name"=>"Adenoma", "asFound"=>"Adenoma", "relevance"=>"HIGH"}, {"id"=>"M13791", "name"=>"Pituitary Diseases", "asFound"=>"Pituitary", "relevance"=>"HIGH"}, {"id"=>"M13802", "name"=>"Pituitary Neoplasms", "asFound"=>"Pituitary Adenoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M10077", "name"=>"Hypothalamic Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M10079", "name"=>"Hypothalamic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17887", "name"=>"Supratentorial Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12367", "name"=>"Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M18937", "name"=>"Central Nervous System Neoplasms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2022-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-04", "studyFirstSubmitDate"=>"2023-12-18", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Recurrence rate of pituitary adenoma", "timeFrame"=>"1 year after treatment", "description"=>"The pituitary adenoma recurred 1 year after treatment. The recurrence was assessed by 3 aspects: (1)contrast enhanced MRI showed suspicious tumor growth, such as bone destruction; (2)signs and symptoms that had disappeared after treatment reappeared, such as pressing on nearby nerve tissue and some characteristic appearance; (3)endocrine indexes rose again after reaching the remission standard, iculding Prolactin(PRL)\\>30 μg/L in Lactotroph adenoma; growth hormone (GH)\\>2.5ng/ml in Somatotroph adenoma, serum cortisol\\>800nmol/L at 8am in Corticotroph adenoma, while other types do not consider endocrine indicators."}], "secondaryOutcomes"=>[{"measure"=>"Pathological type of pituitary adenomas", "timeFrame"=>"1 week after treatment", "description"=>"The pathological examination was used to evaluated the type of pituitary adenoma. The pathological type was assessed by 2017 WHO standard, divided into Somatotroph adenoma, Lactotroph adenoma, Thyrotroph adenoma, Corticotroph adenoma, Gonadotroph adenoma, Null-cell adenoma and Plurihormonal and double adenomas."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pituitary Adenoma"]}, "descriptionModule"=>{"briefSummary"=>"The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics.", "detailedDescription"=>"Inclusion of pituitary adenoma patients diagnosed clinically or pathologically\n\n1. Clinical data and pre-treatment imaging data of included patients (DICOM format)\n2. Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data\n3. Collect relevant data of patients before and after treatment\n4. Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"All participants willing to receive brain imaging could be included in this study", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Gender unlimited, 18-80 years old;\n2. Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;\n3. Received brain imaging;\n4. informed consent signed\n\nExclusion Criteria:\n\n1. Pregnant / lactating women\n2. Contraindications of imaging examination\n3. Lack of effective clinical data\n4. MRI data before treatment cannot be obtained\n5. Postoperative pathology not revealed pituitary adenoma"}, "identificationModule"=>{"nctId"=>"NCT06234553", "acronym"=>"RIPA", "briefTitle"=>"Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma", "organization"=>{"class"=>"OTHER", "fullName"=>"Beijing Tiantan Hospital"}, "officialTitle"=>"Radiomics-based Diagnosis, Treatment and Outcome Prediction for Pituitary Adenoma", "orgStudyIdInfo"=>{"id"=>"SK-748"}, "secondaryIdInfos"=>[{"id"=>"RIPA-001", "type"=>"OTHER", "domain"=>"tiantan hospital"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"training set and validation set", "description"=>"Retrospective study focusing on the diagnosis and treatment outcomes of pituitary adenomas", "interventionNames"=>["Procedure: surgery of pituitary adenomas"]}], "interventions"=>[{"name"=>"surgery of pituitary adenomas", "type"=>"PROCEDURE", "description"=>"evaluate pathological type and treatment effect after treatment", "armGroupLabels"=>["training set and validation set"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100070", "city"=>"Beijing", "country"=>"China", "facility"=>"Beijing tiantan hospital", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}], "overallOfficials"=>[{"name"=>"Yanghua Fan, Dr.", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Beijing Tiantan Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Beijing Tiantan Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
