Viewing Study NCT01110733


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Ignite Modification Date: 2025-12-26 @ 1:34 AM
Study NCT ID: NCT01110733
Status: COMPLETED
Last Update Posted: 2020-01-13
First Post: 2010-04-23
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'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', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2010-04-23', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Non-Hodgkins Lymphoma', "Non-Hodgkin's Lymphoma", 'Lymphoma'], 'conditions': ['Peripheral T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices.', 'detailedDescription': 'The COMPLETE registry is a prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices. The registry will enroll newly-diagnosed patients with PTCL treated with a variety of regimens. The COMPLETE registry is designed to better understand PTCL patient characteristics, treatments, and outcomes to help design and understand future clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be enrolled from academic and community cancer centers in the United States, France, Germany, Italy and Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is newly diagnosed with Peripheral T-cell Lymphoma (PTCL):\n\n * Aggressive natural killer (NK)-cell leukemia\n * Adult T-cell lymphoma/leukemia (human T-cell leukemia virus \\[HTLV\\] 1+)\n * Angioimmunoblastic T-cell lymphoma\n * Anaplastic large cell lymphoma (ALCL), primary systemic type (ALK+, ALK-)\n * PTCL, not otherwise specified (NOS)\n * T/NK-cell lymphoma, nasal type\n * Enteropathy-type intestinal lymphoma\n * Hepatosplenic T-cell lymphoma\n * Subcutaneous panniculitis T-cell lymphoma\n * Transformed mycosis fungoides (at diagnosis of transformation)\n * T-cell prolymphocytic leukemia (T-PLL)\n * Cutaneous gamma/delta (γ/δ) T-cell lymphoma\n * Cutaneous aggressive CD8+ T-cell lymphoma\n * Hematodermic neoplasms (blastic plasmacytoid dendritic cell neoplasm)\n * Systemic Epstein Barr Virus (EBV)+ T-cell lymphomas (T-cell lymphoproliferative disorders of childhood)\n * Other T-Cell lymphomas that are not listed in the Exclusion Criteria\n* Patient gives written informed consent\n\nExclusion Criteria:\n\n* Patient has other T- or NK-cell malignancies including:\n\n * Precursor T/NK neoplasms\n * T-cell large granular lymphocytic leukemia\n * Mycosis fungoides, other than transformed mycosis fungoides\n * Sézary syndrome\n * Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis'}, 'identificationModule': {'nctId': 'NCT01110733', 'acronym': 'COMPLETE', 'briefTitle': 'Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acrotech Biopharma Inc.'}, 'officialTitle': 'Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'COMPLETE Registry'}}, 'contactsLocationsModule': {'locations': [{'zip': '35401', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'DCH Cancer Treatment Center', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Center', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores Cancer Center UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91750', 'city': 'La Verne', 'state': 'California', 'country': 'United States', 'facility': 'Wilshire Oncology Medical Group', 'geoPoint': {'lat': 34.10084, 'lon': -117.76784}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC & Norris Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Olive View Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Hospital Praxair Cancer Center', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Cancer Institute at Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33065', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Coral Springs Oncology', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33463', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Specialists of the Palm Beaches', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33463', 'city': 'Loxahatchee Groves', 'state': 'Florida', 'country': 'United States', 'facility': 'Hematology Oncology Associates', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Anderson Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffit Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Cancer Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30341', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83854', 'city': 'Post Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Kootenai Cancer Center', 'geoPoint': {'lat': 47.71796, 'lon': -116.95159}}, {'zip': '60208', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H. Stroger, Jr. Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'UIC Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Simmons Cooper Cancer Institute at SIU School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Medical Group Oncology and Hematology Associates', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Science Center (LSUHSC)', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '20742', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Hurley Cancer Institute', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48144', 'city': 'Lambertville', 'state': 'Michigan', 'country': 'United States', 'facility': 'ProMedica', 'geoPoint': {'lat': 41.76588, 'lon': -83.62799}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro Minnesota Community Clinical Oncology Program', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07960', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Hospital and Morristown Memorial Hospital', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Clinical Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center Northeast', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Cancer Management, Inc.', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '44035', 'city': 'Lorain', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Cancer Center', 'geoPoint': {'lat': 41.45282, 'lon': -82.18237}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Guthrie Clinic, Ltd', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '37920', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Cancer Institute', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'JPS Center for Cancer Care', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76104', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Oncology and Hematology, P.A.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75766', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Hematology Oncology, PA', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Francine Foss, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acrotech Biopharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}