[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411141":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":26,"locations":35,"responsibleParty":467,"collaborators":10,"id":469,"slug":470,"hasResults":471,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":471,"sex":477,"minAge":478,"maxAge":10,"enrollmentInfo":479,"targetDuration":10,"studyType":482,"phases":10,"briefSummary":483,"conditions":484,"keywords":487,"overallStatus":306,"whyStopped":10,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":501},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients who are receiving a neurotoxic chemotherapy",null,"List of neurotoxic drugs eligible for enrolment\n\n* Platinum drugs\n* Taxanes\n* Vinca alkaloids\n* Epothilones\n* Proteasome inhibitors\n* Thalidomide\n* Vedotin-based drugs\n* checkpoint inhibitors\n* Any combination of the aforementioned drugs",[13],"Other: outcome measures for CIPN testing",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"outcome measures for CIPN testing","questionnaires administration, physician based scales for CIPN data collection",[9],[20,23],{"name":21,"affiliation":5,"role":22},"GUIDO CAVALETTI, MD","STUDY_CHAIR",{"name":24,"affiliation":5,"role":25},"PAOLA ALBERTI, MD","PRINCIPAL_INVESTIGATOR",[27,31],{"name":21,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","+ 39 02 6448 8039","guido.cavaletti@unimib.it",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"PAOLA ALBERTI, MD, PhD","+39 02 6448 8154","paola.alberti@unimib.it",[36,54,70,85,100,114,129,144,159,174,189,204,219,235,246,261,274,289,304,318,334,343,356,368,380,393,408,423,437,452],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Birmingham School of Nursing, University of Alabama","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-86.80249,33.52066,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":10,"phoneExt":10,"email":53},"Ellen M. Lavoie Smith, PhD","esmith3@uab.edu",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Northside Hospital","Atlanta","Georgia","30342",{"type":45,"coordinates":60},[61,62],-84.38798,33.749,{"lat":62,"lon":61},[65,68],{"name":66,"role":28,"phone":10,"phoneExt":10,"email":67},"Guilherme Cantuaria, MD, PhD","Margaret.Ferreira@northside.com",{"name":69,"role":28,"phone":10,"phoneExt":10,"email":10},"Margaret Ferreira",{"facility":71,"status":38,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"JHU","Baltimore","Maryland","21224",{"type":45,"coordinates":76},[77,78],-76.61219,39.29038,{"lat":78,"lon":77},[81],{"name":82,"role":28,"phone":83,"phoneExt":10,"email":84},"Khoshnoodi Mohammad, MD","410-502-7683","mkhoshn1@jhmi.edu",{"facility":86,"status":38,"city":87,"state":88,"zip":89,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Michigan School of Nursing","Ann Arbor","Michigan","48109",{"type":45,"coordinates":91},[92,93],-83.74088,42.27756,{"lat":93,"lon":92},[96],{"name":97,"role":28,"phone":98,"phoneExt":10,"email":99},"Ellen Lavoie Smith, PhD","734-936-1267","ellenls@med.umich.edu",{"facility":101,"status":38,"city":102,"state":102,"zip":103,"country":42,"countryCode":43,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Columbia University Irving Medical Center","New York","10027",{"type":45,"coordinates":105},[106,107],-74.00597,40.71427,{"lat":107,"lon":106},[110],{"name":111,"role":28,"phone":112,"phoneExt":10,"email":113},"Thomas III H Brannagan, MD","212-305-0405","tb2325@cumc.columbia.edu",{"facility":115,"status":38,"city":116,"state":117,"zip":118,"country":42,"countryCode":43,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Cancer Center\u002FWexner Medical Center - Ohio State Medical Oncology Division","Columbus","Ohio","43220",{"type":45,"coordinates":120},[121,122],-82.99879,39.96118,{"lat":122,"lon":121},[125],{"name":126,"role":28,"phone":127,"phoneExt":10,"email":128},"Maryam Lustberg, MD, MPH","410-299-1044","maryam.lustberg@osumc.edu",{"facility":130,"status":38,"city":131,"state":132,"zip":133,"country":42,"countryCode":43,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Dartmouth-Hitchcock Medical Center","Lebanon","Pennsylvania","03756",{"type":45,"coordinates":135},[136,137],-76.41135,40.34093,{"lat":137,"lon":136},[140],{"name":141,"role":28,"phone":142,"phoneExt":10,"email":143},"Victoria H Lawson, MD","603-650-5104","Victoria.H.Lawson@dartmouth.edu",{"facility":145,"status":38,"city":146,"state":147,"zip":148,"country":42,"countryCode":43,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"University of Vermont Medical Center","Burlington","Vermont","05445",{"type":45,"coordinates":150},[151,152],-73.21207,44.47588,{"lat":152,"lon":151},[155],{"name":156,"role":28,"phone":157,"phoneExt":10,"email":158},"Noah Kolb, MD","978-886-2828","Noah.kolb@uvmhealth.org",{"facility":160,"status":38,"city":161,"state":10,"zip":10,"country":162,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Brain and Mind Center","Sydney","Australia","AU",{"type":45,"coordinates":165},[166,167],151.20732,-33.86785,{"lat":167,"lon":166},[170],{"name":171,"role":28,"phone":172,"phoneExt":10,"email":173},"Susanan B Park, PhD","+61293510701","susanna.park@sydney.edu.au",{"facility":175,"status":38,"city":176,"state":10,"zip":10,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Dept. of Neurology, Medical University of Vienna","Vienna","Austria","AT",{"type":45,"coordinates":180},[181,182],16.37208,48.20849,{"lat":182,"lon":181},[185],{"name":186,"role":28,"phone":187,"phoneExt":10,"email":188},"Anna Grisold, MD","004314040031450","anna.grisold@meduniwien.ac.at",{"facility":190,"status":38,"city":191,"state":10,"zip":10,"country":192,"countryCode":193,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"International Centre for Diarrhoeal Disease Research","Dhaka","Bangladesh","BD",{"type":45,"coordinates":195},[196,197],90.40744,23.7104,{"lat":197,"lon":196},[200],{"name":201,"role":28,"phone":202,"phoneExt":10,"email":203},"Badrul Islam","+88 01711595367","bislamdmch@gmail.com",{"facility":205,"status":38,"city":206,"state":10,"zip":10,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Clínica AMO","Salvador","Brazil","BR",{"type":45,"coordinates":210},[211,212],-38.49096,-12.97563,{"lat":212,"lon":211},[215],{"name":216,"role":28,"phone":217,"phoneExt":10,"email":218},"André Muniz, MD","557133116500","Muniz.a@uol.com.br",{"facility":220,"status":38,"city":221,"state":10,"zip":10,"country":222,"countryCode":223,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"The Ottawa Hospital","Ottawa","Canada","CA",{"type":45,"coordinates":225},[226,227],-75.69812,45.41117,{"lat":227,"lon":226},[230],{"name":231,"role":28,"phone":232,"phoneExt":233,"email":234},"Kristopher Dennis, MD","613) 737-7700","70212","krdennis@toh.ca",{"facility":236,"status":237,"city":238,"state":10,"zip":10,"country":239,"countryCode":240,"cosmosGeoPoint":241,"geoPoint":245,"contacts":10},"Aarhus University Hospital","WITHDRAWN","Aarhus","Denmark","DK",{"type":45,"coordinates":242},[243,244],10.21076,56.15674,{"lat":244,"lon":243},{"facility":247,"status":38,"city":248,"state":10,"zip":10,"country":249,"countryCode":250,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Hôpital Percy","Clamart","France","FR",{"type":45,"coordinates":252},[253,254],2.26692,48.80299,{"lat":254,"lon":253},[257],{"name":258,"role":28,"phone":259,"phoneExt":10,"email":260},"Camille Tafani, MD","+33679848495","cdelescalopier@gmail.com",{"facility":262,"status":38,"city":263,"state":10,"zip":10,"country":249,"countryCode":250,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"CHU Dupuytren","Limoges",{"type":45,"coordinates":265},[266,267],1.24759,45.83362,{"lat":267,"lon":266},[270],{"name":271,"role":28,"phone":272,"phoneExt":10,"email":273},"Laurent Magy, MD","+335 55 05 65 68","laurent.magy@unilim.fr",{"facility":275,"status":38,"city":276,"state":10,"zip":10,"country":277,"countryCode":278,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Center for Molecular Medicine","Cologne","Germany","DE",{"type":45,"coordinates":280},[281,282],6.95,50.93333,{"lat":282,"lon":281},[285],{"name":286,"role":28,"phone":287,"phoneExt":10,"email":288},"Helmar Lehmann, MD, PhD","0221-478-87091","helmar.lehmann@uk-koeln.de",{"facility":290,"status":38,"city":291,"state":10,"zip":10,"country":292,"countryCode":293,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"University of Larissa","Larissa","Greece","GR",{"type":45,"coordinates":295},[296,297],22.42112,39.62847,{"lat":297,"lon":296},[300],{"name":301,"role":28,"phone":302,"phoneExt":10,"email":303},"Efthmios Efthmios Dardiotis, MD","+302410685651","edar@med.uth.gr",{"facility":305,"status":306,"city":307,"state":10,"zip":10,"country":292,"countryCode":293,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"\"Saint Andrew's\" State General Hospital","RECRUITING","Pátrai",{"type":45,"coordinates":309},[310,311],21.73508,38.2462,{"lat":311,"lon":310},[314],{"name":315,"role":28,"phone":316,"phoneExt":10,"email":317},"Andreas A Argyriou, MD","+30_2610_227908","andargyriou@yahoo.gr",{"facility":319,"status":306,"city":320,"state":321,"zip":322,"country":323,"countryCode":324,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"San Gerardo Hospital","Monza","Mb","20900","Italy","IT",{"type":45,"coordinates":326},[327,328],9.27246,45.58005,{"lat":328,"lon":327},[331,332,333],{"name":32,"role":28,"phone":10,"phoneExt":10,"email":34},{"name":21,"role":28,"phone":10,"phoneExt":10,"email":30},{"name":32,"role":25,"phone":10,"phoneExt":10,"email":10},{"facility":335,"status":237,"city":336,"state":10,"zip":337,"country":323,"countryCode":324,"cosmosGeoPoint":338,"geoPoint":342,"contacts":10},"Ospedale Valduce","Como","22063",{"type":45,"coordinates":339},[340,341],9.0832,45.80819,{"lat":341,"lon":340},{"facility":344,"status":306,"city":345,"state":10,"zip":10,"country":323,"countryCode":324,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"Ospedale Policlinico San Martino","Genova",{"type":45,"coordinates":347},[348,349],11.87211,45.21604,{"lat":349,"lon":348},[352],{"name":353,"role":28,"phone":354,"phoneExt":10,"email":355},"ANGELO SCHENONE","+ 39 049 8213600","aschenone@neurologia.unige.it",{"facility":357,"status":38,"city":358,"state":10,"zip":10,"country":323,"countryCode":324,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"A.O.U. Policlinico \"G. Martino\"","Messina",{"type":45,"coordinates":360},[361,362],15.55256,38.19394,{"lat":362,"lon":361},[365],{"name":366,"role":28,"phone":10,"phoneExt":10,"email":367},"Massimo Russo, MD","massimo.russo@unime.it",{"facility":369,"status":38,"city":370,"state":10,"zip":10,"country":323,"countryCode":324,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Padova Hospital","Padova",{"type":45,"coordinates":372},[373,374],11.14261,44.38225,{"lat":374,"lon":373},[377],{"name":378,"role":28,"phone":354,"phoneExt":10,"email":379},"BRIANI CHIARA, MD","chiara.briani@unipd.it",{"facility":381,"status":38,"city":382,"state":10,"zip":10,"country":323,"countryCode":324,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Azienda Ospedaliera Universitaria","Verona",{"type":45,"coordinates":384},[385,386],10.9938,45.43854,{"lat":386,"lon":385},[389],{"name":390,"role":28,"phone":391,"phoneExt":10,"email":392},"Stefano Tamburin, MD, PhD","+39 3475235580","stefano.tamburin@univr.it",{"facility":394,"status":38,"city":395,"state":10,"zip":10,"country":396,"countryCode":397,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"Medical Oncoloy Unit - University of Nairobi","Nairobi","Kenya","KE",{"type":45,"coordinates":399},[400,401],36.81667,-1.28333,{"lat":401,"lon":400},[404],{"name":405,"role":28,"phone":406,"phoneExt":10,"email":407},"Ezzi Mohamed, MD","+254721211807","mohammed.ezzi81@gmail.com",{"facility":409,"status":38,"city":410,"state":10,"zip":10,"country":411,"countryCode":412,"cosmosGeoPoint":413,"geoPoint":417,"contacts":418},"Centro Hospitalar Vila Nova de Gaia\u002FEspinho","Vila Nova de Gaia","Portugal","PT",{"type":45,"coordinates":414},[415,416],-8.61241,41.12401,{"lat":416,"lon":415},[419],{"name":420,"role":28,"phone":421,"phoneExt":10,"email":422},"Anabela Amarelo, MD","+351917163485","anabelaamarelo@gmail.com",{"facility":424,"status":306,"city":425,"state":10,"zip":10,"country":426,"countryCode":10,"cosmosGeoPoint":427,"geoPoint":431,"contacts":432},"Dong-A University - Internal Medicine Dept.","Busan","South Korea",{"type":45,"coordinates":428},[429,430],129.03004,35.10168,{"lat":430,"lon":429},[433],{"name":434,"role":28,"phone":435,"phoneExt":10,"email":436},"Ji H Lee, MD","82-51-240-5044","hidrleejh@dau.ac.kr",{"facility":438,"status":306,"city":439,"state":10,"zip":10,"country":440,"countryCode":441,"cosmosGeoPoint":442,"geoPoint":446,"contacts":447},"Hospital Universitari de Bellvitge-ICO L'Hospitalet","Barcelona","Spain","ES",{"type":45,"coordinates":443},[444,445],2.15899,41.38879,{"lat":445,"lon":444},[448],{"name":449,"role":28,"phone":450,"phoneExt":10,"email":451},"Jordi Bruna, MD, PhD","0034932607711","jbruna@bellvitgehospital.cat",{"facility":453,"status":38,"city":454,"state":10,"zip":10,"country":455,"countryCode":456,"cosmosGeoPoint":457,"geoPoint":461,"contacts":462},"University of Basel - Department of Sport, Exercise and Health","Basel","Switzerland","CH",{"type":45,"coordinates":458},[459,460],7.57327,47.55839,{"lat":460,"lon":459},[463],{"name":464,"role":28,"phone":465,"phoneExt":10,"email":466},"Fiona Streckmann, MD","+41 (0) 61 207 47 30","fiona.streckmann@unibas.ch",{"type":468,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100411141","international-cipn-assessment-and-validation-study-100411141",false,"NCT04633655","International CIPN Assessment and Validation Study","International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study","ICAVS","Inclusion Criteria\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:\n\n1. Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).\n2. Male and female subjects who are 18 years of age or older.\n3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.\n4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.\n5. Subjects must have a Karnofsky performance score greater than or equal to 70. Exclusion Criteria\n\nSubjects presenting with any of the following will not be included in the study:\n\n1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.\n2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.\n3. Severe depression that in the opinion of the Investigator would complicate the assessments.\n4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.\n5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).\n6. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g. metronidazole, isoniazid, amiodarone, antiretroviral medications).\n7. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.\n8. Previous neurotoxic chemotherapy.","ALL","18 Years",{"count":480,"type":481},1000,"ESTIMATED","OBSERVATIONAL","This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.",[485,486],"Chemotherapy-induced Peripheral Neuropathy","Quality of Life",[488,489,490,491],"clinimetrics","biomarker","PRO","outcome measures","2025-07-24",{"date":494,"type":495},"2025-07-25","ACTUAL",{"date":497,"type":495},"2020-06-08",{"date":499,"type":481},"2025-12-31",{"name":5,"class":6},30]