[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100256852":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":69,"collaborators":71,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":10,"enrollmentInfo":116,"targetDuration":119,"studyType":120,"phases":10,"briefSummary":121,"conditions":122,"keywords":10,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"AIO-Studien-gGmbH","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"NSCLC, Non-squamous cell carcinoma",null,"Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.\n\nAt least 3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP)",[13],"Other: data collection",{"label":15,"type":10,"description":16,"interventionNames":17},"NSCLC, Squamous cell carcinoma","Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.\n\nAt least 1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"NSCLC, Non-squamous cell carcinoma (not tested)","Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.\n\nUp to 5,000 patients not tested for molecular alterations (CRISP satellite untested patients stage IIIB\u002FIIIC\u002FIV).).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"NSCLC, Stage I\u002FII\u002FIII","Up to 1600 patients with NSCLC stage I, or stage II, or stage IIIA, or with NSCLC stage IIIB\u002FC if they are eligible for curative surgery and\u002For radiochemotherapy, or are receiving best supportive care",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Small cell lung cancer (SCLC)","Up to 1200 patients with SCLC (limited stage (LD) or extensive stage (ED)) if they are eligible for surgery and\u002For radio(chemo)therapy and\u002For systemic therapy, or are receiving best supportive care",[13],[31],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"data collection","Baseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.",[9,19,15,23,27],[36],{"name":37,"affiliation":38,"role":39},"Frank Griesinger, Prof. Dr.","Pius-Hospital Oldenburg","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Annika Groth","CONTACT","+49 30-8145344-39","annika.groth@aio-studien-ggmb.de",{"name":47,"role":43,"phone":48,"phoneExt":10,"email":49},"Paula Ludwig","+49 30-8145344-63","Paula.Ludwig@aio-studien-ggmbh.de",[51],{"facility":52,"status":53,"city":54,"state":10,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Pius-Hospital","RECRUITING","Oldenburg","26121","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.21479,53.14039,{"lat":62,"lon":61},[65],{"name":66,"role":43,"phone":67,"phoneExt":10,"email":68},"F. Griesinger, Prof.","+49 441 229 1611","Frank.griesinger@pius-hospital.de",{"type":70,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[72,75,77,79,81,83,85,87,89,91,93,95,97,99,101,103,105],{"name":73,"class":74},"AstraZeneca","INDUSTRY",{"name":76,"class":74},"Celgene Corporation",{"name":78,"class":74},"Merck Sharp & Dohme LLC",{"name":80,"class":74},"Novartis Pharmaceuticals",{"name":82,"class":74},"Pfizer",{"name":84,"class":74},"Boehringer Ingelheim",{"name":86,"class":74},"Bristol-Myers Squibb",{"name":88,"class":74},"iOMEDICO AG",{"name":90,"class":74},"Eli Lilly and Company",{"name":92,"class":74},"Roche Pharma AG",{"name":94,"class":74},"Takeda",{"name":96,"class":74},"Amgen",{"name":98,"class":74},"Janssen-Cilag G.m.b.H",{"name":100,"class":74},"GlaxoSmithKline",{"name":102,"class":74},"Daiichi Sankyo",{"name":104,"class":74},"Regeneron Pharmaceuticals",{"name":106,"class":74},"Gilead Sciences","100256852","clinical-research-platform-into-molecular-testing-treatment-and-outcome-of-non-small-cell-lung-carcinoma-patients-100256852",false,"NCT02622581","Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients","CRISP","Inclusion Criteria:\n\nPatients who meet all of the following criteria are eligible for the project:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments\n\nMain project (Metatstatic NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\"\n* Stage IV, or stage IIIB\u002FC (UICC8) if patient is ineligible for curative surgery and\u002For radiochemotherapy\n* Systemic therapy or best supportive care\n\nSatellite Stage I\u002FII\u002FIII (NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Stage I, Stage II, stage IIIA, or stage IIIB\u002FC (UICC8)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nSatellite SCLC\n\n* Confirmed Small cell lung cancer (SCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nExclusion Criteria:\n\nnone","ALL","18 Years",{"count":117,"type":118},12400,"ESTIMATED","3 Years","OBSERVATIONAL","Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany",[123,124,125,126,127,128],"Metastatic Non-small Cell Lung Cancer (NSCLC)","Non-small Cell Lung Cancer Metastatic","Non-small Cell Lung Cancer Stage II","Non Small Cell Lung Cancer Stage III","Small-cell Lung Cancer","Non-small Cell Lung Cancer Stage I","2025-02-14",{"date":131,"type":132},"2025-02-18","ACTUAL",{"date":134,"type":132},"2015-12",{"date":136,"type":118},"2027-12",{"name":5,"class":6},1]