Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-18 @ 2:48 AM
Study NCT ID:
NCT02999750
Status:
UNKNOWN
Last Update Posted:
2016-12-21
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXtendedAnalysis for Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-16', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of real time biopsy to establish an individual molecular profile by using next generation sequencing', 'timeFrame': '2 years', 'description': 'pathological examination (includes genetic and target expression profiling, and drug sensitivity screening) to rank treatment options and the potential correlation between treatment response and progression free survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively validate treatment benefit of an individualized treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue sections obtained before the start of treatment (real time biopsy).', 'detailedDescription': 'The treatment concept will be considered to be of clinical benefit for the individual patient if a progression-free survival (PFS) ratio (PFS on MP-based therapy / best PFS achieved by prior therapy) will be \\> 1.0 thus generating a patient cohort with this very property. Thereby, the null hypothesis (that ≤ 40 % of this patient population would have a PFS ratio of \\> 1.0) will be evaluated with each patient being his own control. For tumor types with high numbers of patients per cohort, the overall response rate (ORR) will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nConsenting patients of \\>19 years with advanced cancer fulfilling the criteria of having:\n\n* an advanced malignancy with metastatic spread refractory to conventional treatment\n* a life expectancy of \\>4 months,\n* the possibility to access and biopsy tumour material within 4 weeks before onset of individualized treatment,\n* a malignancy amenable to further treatment options with either cytotoxic drugs, tyrosine kinase inhibitors, monoclonal antibodies or related molecules with anti-proliferative potential to cancer cells, as assessed by the ex vivo analysis and a likelihood of treatment response according to the mathematical model (all outlined in detail above),\n* agreed to participate by their signature on an informed consent form are eligible.\n\nExclusion Criteria:\n\n* Presence of further treatment options, as defined by NCCN guidelines which are available in Austria representing a possible further treatment-related response by conventional therapies according to generally accepted medical evidence.\n* No fresh and viable tumor material available.\n* Current use of therapeutic warfarin.\n* Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia.\n* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.\n* A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.\n* A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n* History of other malignancy. Subjects who have been disease-free for 5 years or those with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.\n* Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol)\n* unwillingness or inability to follow the procedures required in the protocol.\n* pregnant or lactating females.\n* History of alcohol or drug abuse within 6 months prior to screening.\n* No informed consent available.'}, 'identificationModule': {'nctId': 'NCT02999750', 'briefTitle': 'EXtendedAnalysis for Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'EXACT: EXtendedAnalysis for Cancer Treatment A Prospective Investigator-initiated Translational Study Evaluating Individualized Treatment Regiments Based on Respective Biomarker Analyses for Refractory Cancer Patients', 'orgStudyIdInfo': {'id': 'EXACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'individual therapy', 'description': 'individual therapy', 'interventionNames': ['Other: individual therapy']}], 'interventions': [{'name': 'individual therapy', 'type': 'OTHER', 'description': 'Patient will be treated with individual therapy.', 'armGroupLabels': ['individual therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'AKH Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ. Prof. Dr.', 'investigatorFullName': 'Gerald Prager', 'investigatorAffiliation': 'Medical University of Vienna'}}}}