Nctid:
NCT06231524
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}, {"id"=>"D000009362", "term"=>"Neoplasm Metastasis"}], "ancestors"=>[{"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}, {"id"=>"D000009385", "term"=>"Neoplastic Processes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Metastases", "relevance"=>"HIGH"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Cancer", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"Primary tumor"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall survival", "timeFrame"=>"At least 1-year follow up", "description"=>"The time between the date of diagnosis and the date of death (due to any cause) or the date of last follow-up."}], "secondaryOutcomes"=>[{"measure"=>"Progression-free survival", "timeFrame"=>"At least 1-year follow up", "description"=>"The time from diagnosis to the onset of disease progression."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Colorectal Cancer", "Synchronous peritoneal metastasis", "DNA ploidy", "Stroma-tumor fraction", "Nucleotyping"], "conditions"=>["Colorectal Cancer", "Peritoneal Metastases"]}, "descriptionModule"=>{"briefSummary"=>"Heterogeneity concerning survival in synchronous peritoneal metastasis from patients with colorectal cancer exists, thereby further classification is urgently required. This study aimed to validate a PSN-AI model based on DNA ploidy, stroma-tumor fraction, and nucleotyping (PSN) for the prediction of survival of synchronous peritoneal metastasis from colorectal cancer."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who underwent cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Histological proof of synchronous peritoneal metastases of a nonappendiceal colorectal adenocarcinoma.\n* Resectable disease determined by computed tomography (CT) and a peritoneal cancer index (PCI) of ≤20 at diagnostic laparoscopy or laparotomy;\n* No evidence of systemic (e.g. liver, lung) colorectal metastases within three months prior to enrolment;\n* Undergoing cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.\n\nExclusion Criteria:\n\n* Combined with other types of malignant tumors."}, "identificationModule"=>{"nctId"=>"NCT06231524", "acronym"=>"PSN-AI", "briefTitle"=>"Development and Validation of a PSN-AI Prediction Model", "organization"=>{"class"=>"OTHER", "fullName"=>"Sixth Affiliated Hospital, Sun Yat-sen University"}, "officialTitle"=>"Development and Validation of a AI Prognostic Model Based on DNA Ploidy, Stroma, and Nucleotyping for Synchronous Peritoneal Metastasis From Colorectal Cancer", "orgStudyIdInfo"=>{"id"=>"PSN2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Validation cohort", "description"=>"A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model validation.", "interventionNames"=>["Other: Analyse pathologic slides"]}], "interventions"=>[{"name"=>"Analyse pathologic slides", "type"=>"OTHER", "description"=>"HE-stained whole slide images were used for the validation of the PSN-AI model.", "armGroupLabels"=>["Validation cohort"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"510000", "city"=>"Guangzhou", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Qiyuan Qin, M.D.", "role"=>"CONTACT", "email"=>"qinqy3@mail.sysu.edu.cn", "phone"=>"86-20-38254052"}], "facility"=>"Sixth Affiliated Hospital, Sun Yat-sen University", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}], "centralContacts"=>[{"name"=>"Qiyuan Qin, PhD", "role"=>"CONTACT", "email"=>"qinqy3@mail.sysu.edu.cn", "phone"=>"+86-20-38254052"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sixth Affiliated Hospital, Sun Yat-sen University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
