Nctid:
NCT06235853
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001749", "term"=>"Urinary Bladder Neoplasms"}, {"id"=>"D000093284", "term"=>"Non-Muscle Invasive Bladder Neoplasms"}, {"id"=>"D000018450", "term"=>"Disease Progression"}, {"id"=>"D000012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D000014571", "term"=>"Urologic Neoplasms"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000001745", "term"=>"Urinary Bladder Diseases"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}], "browseLeaves"=>[{"id"=>"M20559", "name"=>"Disease Progression", "asFound"=>"Progression", "relevance"=>"HIGH"}, {"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrence", "relevance"=>"HIGH"}, {"id"=>"M5030", "name"=>"Urinary Bladder Neoplasms", "asFound"=>"Bladder Cancer", "relevance"=>"HIGH"}, {"id"=>"M2976", "name"=>"Non-Muscle Invasive Bladder Neoplasms", "asFound"=>"Non-muscle Invasive Bladder Cancer", "relevance"=>"HIGH"}, {"id"=>"M17320", "name"=>"Urologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M5026", "name"=>"Urinary Bladder Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13848", "name"=>"Plasminogen", "relevance"=>"LOW"}, {"id"=>"M19671", "name"=>"Plasminogen Activator Inhibitor 1", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Fibrinolytic Agents", "abbrev"=>"FiAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"Blood (10 ml) and urine (10 ml) specimen"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>240}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-04-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Tumour recurrence or progression", "timeFrame"=>"Up to 1 year", "description"=>"Tumour recurrence or progression based on histopathological result from specimen from follow-up cystoscopy."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Non-muscle Invasive Bladder Cancer", "Cystoscopy", "Recurrence", "Progression", "Bladder Cancer", "Biomarkers"], "conditions"=>["Non-muscle Invasive Bladder Cancer", "Cystoscopy", "Recurrence", "Progression", "Bladder Cancer", "Biomarkers"]}, "descriptionModule"=>{"briefSummary"=>"Bladder cancer (BC) is one of the most common type of cancer globally. Due to its high incidence rate, high risk of recurrence and progression, and frequent cystoscopy surveillance, BC contributes to major healthcare costs across the world. The goal of this prospective study was to evaluate the prognostic value of novel non-muscle invasive bladder cancer (NMIBC) biomarkers for predicting disease recurrence or progression after radical transurethral resection of bladder tumour (TURBT). The data obtained from this study may help physicians identify patients who are at greater risk of NMIBC recurrence or progression and require close supervision.", "detailedDescription"=>"The aim of our prospective study was to determine the prognostic impact of the inflammatory response and indicators of nutritional status on recurrence and progression of non-muscle invasive bladder cancer (NMIBC) in patients undergoing transurethral resection of bladder tumour (TURBT). We evaluated six biomarkers, 3 in blood serum: soluble urokinase plasminogen activator receptor (sUPAR), plasminogen activator inhibitor-1 (PAI-1), interleukin 8 (IL-8) and 3 in urine: apolipoprotein E (APOE), vascular endothelial growth factor (VEGF), interleukin 8 (IL-8). Furthermore, following indicators of nutritional status were investigated: Glasgow Prognostic Score (GPS) and Modified Glasgow Prognostic Score (mGPS).\n\nThe primary endpoint of this study was the recurrence or progression of NMIBC based on the histopathological or cystoscopic result. The study outcome was evaluated during the first surveillance cystoscopy, which was performed in time intervals indicated by European Association of Urology. Based on literature data and statistical assumptions we aimed to recruit 240 patients with NMIBC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with suspicion of bladder cancer", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Signed informed consent form\n* Presence or suspicion of tumour in urinary bladder\n* Qualification for the first transurethral resection of bladder tumour\n\nExclusion Criteria:\n\n1. age \\< 18 years\n2. active urinary tract infection\n3. active autoimmune disease\n4. end-stage renal failure and renal replacement therapy\n5. active hepatitis A, B or C\n6. active HIV infection\n7. pregnancy\n8. factors disqualifying the patient from adjuvant treatment (intravesical immunotherapy or intravesical chemotherapy)\n9. bladder tumour stage T2 or more, or urothelial tumour in a location other than the urinary bladder\n10. other cancer or systemic anticancer treatment carried out up to 5 years ago\n11. factors disqualifying the patient from surgical treatment, e.g. coagulopathies\n12. lack of patient consent to collection of blood and urine samples and to follow-up visits"}, "identificationModule"=>{"nctId"=>"NCT06235853", "briefTitle"=>"Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Wroclaw Medical University"}, "officialTitle"=>"Biomarkers of Recurrence and Progression in Non-muscle Invasive Bladder Cancer - an Association With Inflammatory Response and Plasminogen Activation System", "orgStudyIdInfo"=>{"id"=>"0073/DIA/2019/48_KB"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients after TURBT with NMIBC", "description"=>"Patients who underwent successful TURBT with histopathological proof of non-muscle invasive bladder cancer. Blood and urine specimen have been gathered prior to hospital admission during visit in out-patient clinic.", "interventionNames"=>["Diagnostic Test: Blood serum: sUPAR, PAI-1, IL-8.", "Diagnostic Test: Urine: IL-8, APOE, VEGF."]}], "interventions"=>[{"name"=>"Blood serum: sUPAR, PAI-1, IL-8.", "type"=>"DIAGNOSTIC_TEST", "description"=>"The concentration of described biomarkers were measured in serum.", "armGroupLabels"=>["Patients after TURBT with NMIBC"]}, {"name"=>"Urine: IL-8, APOE, VEGF.", "type"=>"DIAGNOSTIC_TEST", "description"=>"The concentration of described biomarkers were measured in urine.", "armGroupLabels"=>["Patients after TURBT with NMIBC"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"50-367", "city"=>"Wrocław", "country"=>"Poland", "facility"=>"Wroclaw Medical University", "geoPoint"=>{"lat"=>51.1, "lon"=>17.03333}}], "overallOfficials"=>[{"name"=>"Klaudia Bardowska, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Wroclaw Medical University"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["ANALYTIC_CODE"], "timeFrame"=>"Unlimited", "ipdSharing"=>"YES", "description"=>"Anonymised data will be published in open access repository after publication of study results.", "accessCriteria"=>"Unlimited"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Wroclaw Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
