Nctid:
NCT06229522
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010051", "term"=>"Ovarian Neoplasms"}, {"id"=>"D000077216", "term"=>"Carcinoma, Ovarian Epithelial"}], "ancestors"=>[{"id"=>"D000004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000010049", "term"=>"Ovarian Diseases"}, {"id"=>"D000000291", "term"=>"Adnexal Diseases"}, {"id"=>"D000005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000006058", "term"=>"Gonadal Disorders"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}], "browseLeaves"=>[{"id"=>"M12974", "name"=>"Ovarian Neoplasms", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"M1704", "name"=>"Carcinoma, Ovarian Epithelial", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12972", "name"=>"Ovarian Diseases", "relevance"=>"LOW"}, {"id"=>"M3643", "name"=>"Adnexal Diseases", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "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"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M9163", "name"=>"Gonadal Disorders", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"T4352", "name"=>"Ovarian Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"T4354", "name"=>"Ovarian Epithelial Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>150}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2037-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2023-12-12", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2037-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To assess if the drugs' sensibility tested in the 3D organoids derived from biopsies could predict the clinical response (PFS) to therapy regimen for each individual ovarian cancer patient.", "timeFrame"=>"up to 36 months", "description"=>"Patients will be divided into two groups based on IC50 level. Difference in PFS probability between patients with high or low IC50 level will be assessed. Progression-free survival (PFS) will be defined as time from enrolment to progression or death whichever comes first"}, {"measure"=>"To assess if the drugs' sensibility tested in the 3D organoids derived from ascites fluids could predict the clinical response (PFS) to therapy regimen for each individual ovarian cancer patient.", "timeFrame"=>"up to 36 months", "description"=>"Patients will be divided into two groups based on IC50 level. Difference in PFS probability between patients with high or low IC50 level will be assessed. Progression-free survival (PFS) will be defined as time from enrolment to progression or death whichever comes first"}, {"measure"=>"To assess if the drugs' sensibility tested in the 3D organoids derived from biopsies could predict the clinical response (PFI) to therapy regimen for each individual ovarian cancer patient.", "timeFrame"=>"up to 36 months", "description"=>"Patients will be divided into two groups based on IC50 level. Difference in platinum-free interval for platinum salts (PFI) probability between patients with high or low IC50 level will be assessed. PFI will be defined as time from the date of last dose of first line chemotherapy to the date of first recurrence."}, {"measure"=>"To assess if the drugs' sensibility tested in the 3D organoids derived from ascites fluid could predict the clinical response (PFI) to therapy regimen for each individual ovarian cancer patient.", "timeFrame"=>"up to 36 months", "description"=>"Patients will be divided into two groups based on IC50 level. Difference in platinum-free interval for platinum salts (PFI) probability between patients with high or low IC50 level will be assessed. PFI will be defined as time from the date of last dose of first line chemotherapy to the date of first recurrence."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Ovarian Cancer"]}, "descriptionModule"=>{"briefSummary"=>"The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.", "detailedDescription"=>"The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"This study will include all consecutive women with a diagnosis of ovarian cancer who fit all inclusion/exclusion criteria between the date in which the study is approved and December 2027. Follow-up information will be collected up to 10 years since enrollment.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Signed informed consent form;\n2. Female sex;\n3. Age ≥18 years;\n4. Diagnosis of ovarian cancer;\n5. Availability of tumor sample or ascites that is planned to be stored in the Institutional Biobank for research purpose\n\nExclusion Criteria:\n\n1. Patients for which the tumor/ascites biobanking process could compromise the diagnostic assessments;\n2. Pregnancy or breast-feeding\n3. History of concomitant or previous malignancy in the last 5 years"}, "identificationModule"=>{"nctId"=>"NCT06229522", "acronym"=>"PANDORA", "briefTitle"=>"Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA).", "organization"=>{"class"=>"OTHER", "fullName"=>"Centro di Riferimento Oncologico - Aviano"}, "officialTitle"=>"Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA)", "orgStudyIdInfo"=>{"id"=>"CRO-2022-45"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33081", "city"=>"Aviano", "state"=>"Pordenone", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Vincenzo Canzonieri", "role"=>"CONTACT", "email"=>"vcanzonieri@cro.it", "phone"=>"0434659618"}], "facility"=>"Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS", "geoPoint"=>{"lat"=>46.07056, "lon"=>12.59472}}], "centralContacts"=>[{"name"=>"Vincenzo Canzonieri, MD", "role"=>"CONTACT", "email"=>"vcanzonieri@cro.it", "phone"=>"0434659618"}], "overallOfficials"=>[{"name"=>"Vincenzo Canzonieri, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centro di Riferimento Oncologico - Aviano", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
