Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-28 @ 1:39 AM
Study NCT ID:
NCT01151358
Status:
UNKNOWN
Last Update Posted:
2010-06-28
First Post:
2010-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-25', 'studyFirstSubmitDate': '2010-06-24', 'studyFirstSubmitQcDate': '2010-06-25', 'lastUpdatePostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Detection of diagnostical relevance of FDG-PET- and CT-image data findings in staging and re-staging of follicular non-Hodgkin´s lymphoma as well as in documentation of patient´s outcome after standard radioimmunotherapy', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radioimmunotherapy', 'follicular non-Hodgkin´s lymphoma', 'FDG-PET', 'prognostic factors', 'multicenter study'], 'conditions': ['Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive.\n\nBased on these documented clinical and imaging data, the MERIT study group centrally performs an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who suffer from a relapsed and/or refractory follicular non-Hodgkin´s lymphoma (FL) or patients with partial remission after induction chemotherapy of FL', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* standard radioimmunotherapy with 90-yttrium-labeled anti-CD20-antibodies in treatment of relapsed and/or refractory follicular NHL or partial remission after induction chemotherapy\n* finding of at least one image-guided measurable lymphoma lesion\n* existence of FDG-PET- and CT-image data of at most 8 weeks before treatment\n* signed patient´s agreement for RIT registry and MERIT-NHL\n\nExclusion Criteria:\n\n* other therapy modalities than standard radioimmunotherapy (e.g. consolidation)\n* solely CNS-lymphoma or primary effusion lymphoma'}, 'identificationModule': {'nctId': 'NCT01151358', 'acronym': 'MERIT-NHL', 'briefTitle': 'Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Multicenter Prospective Evaluation of Patient- and Lesion Specific Prognostic Factors for Standard RadioImmunoTherapy With 90-Yttrium-labeled Anti-CD20 in Follicular Non-Hodgkin´s Lymphoma', 'orgStudyIdInfo': {'id': 'MERIT-NHL'}}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg (Saar)', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Aleksandar Grgic, MD', 'role': 'CONTACT', 'email': 'merit@uks.eu', 'phone': '+49-6841-16-22201'}], 'facility': 'Dept. of Nuclear Medicine, Saarland University Hospital', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'Karlsruhe', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Cornelia Puskas, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Karlsruhe, Dept. of Nuclear Medicine', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '23538', 'city': 'Lübeck', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'University Clinic Kiel-Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klemens Scheidhauer, MD', 'role': 'CONTACT'}], 'facility': 'Technical University, Dept. of Nuclear Medicine', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Aleksandar Grgic, MD', 'role': 'CONTACT', 'email': 'merit@uks.eu', 'phone': '+49-6841-16-22201'}, {'name': 'Anja Hoock', 'role': 'CONTACT', 'email': 'merit@uks.eu', 'phone': '+49-6841-16-22201'}], 'overallOfficials': [{'name': 'Carl-Martin Kirsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinikum des Saarlandes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carl-Martin Kirsch, MD', 'oldOrganization': 'University Hospital, Saarland'}}}}