Nctid:
NCT06236464
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000002294", "term"=>"Carcinoma, Squamous Cell"}, {"id"=>"D000077195", "term"=>"Squamous Cell Carcinoma of Head and Neck"}, {"id"=>"D000001005", "term"=>"Anus Neoplasms"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000018307", "term"=>"Neoplasms, Squamous Cell"}, {"id"=>"D000006258", "term"=>"Head and Neck Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000012004", "term"=>"Rectal Neoplasms"}, {"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}, {"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000001004", "term"=>"Anus Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M1689", "name"=>"Squamous Cell Carcinoma of Head and Neck", "asFound"=>"Squamous Cell Carcinoma of the Head and Neck", "relevance"=>"HIGH"}, {"id"=>"M5550", "name"=>"Carcinoma, Squamous Cell", "asFound"=>"Squamous Cell Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M4321", "name"=>"Anus Neoplasms", "asFound"=>"Carcinoma of the anus", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M20451", "name"=>"Neoplasms, Squamous Cell", "relevance"=>"LOW"}, {"id"=>"M9348", "name"=>"Head and Neck Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14846", "name"=>"Rectal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "relevance"=>"LOW"}, {"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"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M4320", "name"=>"Anus Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}, {"id"=>"T362", "name"=>"Anal Cancer", "asFound"=>"Carcinoma of the anus", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>170}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-09-25", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-03", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-11-19", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Primary Endpoint", "timeFrame"=>"30 months", "description"=>"Identify shared molecular profiles in squamous cell carcinomas (SCC) of the mucosa of the anogenital tract and head-neck region, dependent on the presence of somatic mutations (e.g., TERT promoter mutations and viral HPV sequences)."}], "secondaryOutcomes"=>[{"measure"=>"Secondary Endpoint", "timeFrame"=>"30 months", "description"=>"Inhibition of growth in organoids obtained from tumor cells mutated in the TERT promoter or expressing viral oncogenes and SIRT1."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Squamous Cell Carcinoma of the Head and Neck", "Squamous Cell Carcinoma of the Anus"]}, "descriptionModule"=>{"briefSummary"=>"This is a multicentric, retrospective, and prospective biomarker study.", "detailedDescription"=>"This is a multicentric, retrospective, and prospective biomarker study, involving a total of 170 patients with SCC (Squamous Cell Carcinoma) of the mucosa of the anogenital tract and head-neck region, recruited from INT-NA (n=50), UPO (n=40), AOUP (n=40), and ITB (n=40). Specifically, retrospective and prospective samples will be collected and analyzed for the study of molecular and viral biomarkers. Simultaneously, fibroblastic tumor-associated cells (CAFs) will be isolated from prospective samples. Through co-cultivation with immortalized cell lines derived from anogenital and head-neck SCCs, these CAFs will enable the production of 3D organoids for use in experiments assessing the response to telomerase and deacetylase SIRT1 inhibitors, both in vitro and in preclinical models."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"The study population consists of patients with a histological diagnosis of squamous cell carcinoma (SCC) of the anus, cervix, vulva, oral cavity, and oropharynx. At least 170 cases of anal SCC (n=30), cervical SCC (n=30), vulvar SCC (n=30), oral cavity SCC (n=40), and oropharyngeal SCC (n=40) will be prospectively enrolled and retrospectively analyzed.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nPatients aged ≥ 18 years, candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, and head-neck region (including microinvasive and invasive carcinomas) who are capable of understanding and willing to sign the informed consent form. Prospective patients must provide written informed consent before any procedures.\n\nExclusion Criteria:\n\nPatients presenting any of the following criteria are not eligible for inclusion in this study. Exclusion criteria include:\n\n1. Metastatic neoplasia\n2. Treatment for other oncological pathologies\n3. Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)"}, "identificationModule"=>{"nctId"=>"NCT06236464", "briefTitle"=>"Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas", "organization"=>{"class"=>"OTHER", "fullName"=>"National Cancer Institute, Naples"}, "officialTitle"=>"Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas of the Anogenital Tract and of the Head-neck Region for the Development of Shared Therapeutic Strategies", "orgStudyIdInfo"=>{"id"=>"PNRR-MAD-2022-12376570"}, "secondaryIdInfos"=>[{"id"=>"9/23 oss", "type"=>"OTHER", "domain"=>"IRCCS I.N.T. \"G. Pascale\""}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Multiparameter analysis of each sample", "type"=>"OTHER", "description"=>"Retrospective and prospective samples will be collected and analyzed for the study of molecular and viral biomarkers. Simultaneously, fibroblastic tumor-associated cells (CAFs) will be isolated from prospective samples. Through co-cultivation with immortalized cell lines derived from anogenital and head-neck SCCs, these CAFs will enable the production of 3D organoids for use in experiments assessing the response to telomerase and deacetylase SIRT1 inhibitors, both in vitro and in preclinical models."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"70124", "city"=>"Bari", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Oronzo Brunetti, M.D", "role"=>"CONTACT", "email"=>"dr.oronzo.brunetti1983@gmail.com"}], "facility"=>"Istituto Tumori IRCCS Giovanni Paolo II di Bari", "geoPoint"=>{"lat"=>41.11148, "lon"=>16.8554}}, {"zip"=>"80131", "city"=>"Napoli", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Maria Lina Tornesello, M.D.", "role"=>"CONTACT", "email"=>"m.tornesello@istitutotumori.na.it", "phone"=>"08117770588"}], "facility"=>"Istituto Nazionale Tumori | \"Fondazione Pascale\"", "geoPoint"=>{"lat"=>40.85216, "lon"=>14.26811}}, {"zip"=>"28100", "city"=>"Novara", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Marisa Gariglio, M.D.", "role"=>"CONTACT", "email"=>"marisa.gariglio@med.uniupo.it"}], "facility"=>"Università del Piemonte orientale", "geoPoint"=>{"lat"=>45.44694, "lon"=>8.62118}}, {"zip"=>"56126", "city"=>"Pisa", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Mauro Pistello, M.D.", "role"=>"CONTACT", "email"=>"mauro.pistello@unipi.it", "phone"=>"050 221 3781"}], "facility"=>"Azienda Ospedaliera Universitaria Pisana", "geoPoint"=>{"lat"=>43.70853, "lon"=>10.4036}}], "centralContacts"=>[{"name"=>"Maria Lina Tornesello, M.D.", "role"=>"CONTACT", "email"=>"m.tornesello@istitutotumori.na.it", "phone"=>"08117770588"}], "overallOfficials"=>[{"name"=>"Maria Lina Tornesello, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"IRCCS I.N.T. \"G. Pascale\""}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute, Naples", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
