Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-04-02 @ 5:08 AM
Study NCT ID:
NCT00498667
Status:
WITHDRAWN
Last Update Posted:
2015-05-06
First Post:
2007-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'no biopsies are to be retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2007-07-08', 'studyFirstSubmitQcDate': '2007-07-08', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PET/CT', 'Aggressive non-Hodgkin Lymphoma'], 'conditions': ['Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse']}, 'descriptionModule': {'briefSummary': 'A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma.', 'detailedDescription': 'Patients who were treated for aggressive non-Hodgkin lymphoma with adriamycin containing regimen, CHOP and High dose CHOP with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . Currently a retrospective evaluation of PET/CT as a predictive value for progression free survival and overall survival is evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with agressive non hodgkin lymphoma who had interim pet/ct during therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aggressive non-Hodgkin lymphoma b cells\n* age 18-70\n* bilirubin less then 2\n* creatinine less then 2\n* Pet/CT performed post 2 cycles\n\nExclusion Criteria:\n\n* no PET/CT post 2 cycles performed\n* bilirubin \\>2\n* creatinine more then 2\n* HIV positivity'}, 'identificationModule': {'nctId': 'NCT00498667', 'briefTitle': 'The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Evaluation of the Prognostic Value of Early Interim PET/CT for Prediction of Progression Free Survival of Patients With Aggressive B Cells Non Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'cc-NHL2615_CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PET/CT', 'description': 'all patients with aggressive lymphoma who had a baseline and interim pet/ct study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'RAMBAM health care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Eldad J Dann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RAMBAM health care campus,Rappaport faculty of medicine Technion Israel Technical institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Eldad Dann', 'investigatorFullName': 'e_dann', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}