Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT02682667
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015459', 'term': 'Leukemia-Lymphoma, Adult T-Cell'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11-18', 'completionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sample Acquisition', 'timeFrame': 'Ongoing', 'description': 'Biospecimen collection for study and understanding of disease.'}], 'secondaryOutcomes': [{'measure': 'Associations between clinical parameters, biospecimen characteristics and patient demographics', 'timeFrame': 'Ongoing', 'description': 'Correlation of these characteristics with disease.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Apheresis Products', 'Immunological', 'Diverse Malignan', 'Premalignant', 'Protein', 'Natural History'], 'conditions': ['Multiple Myeloma', 'Lymphoma, Non-Hodgkin', 'Leukemia-Lymphoma, Adult T-Cell', 'Hodgkin Disease', 'Non-Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2016-C-0061.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nCancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.\n\nObjective:\n\nTo better understand the biology of malignancies and why certain cancers respond differently to treatment.\n\nEligibility:\n\nAdults at least 18 years old with cancer or a pre-cancerous condition.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.\n\nParticipants will send tissue blocks or slides from their original tumor biopsy.\n\nAt least once, participants will have a medical history, physical exam, and blood and urine tests.\n\nParticipants may have the following tests. They may have them more than once:\n\nApheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.\n\nBone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.\n\nPiece of cancer tissue taken by a needle and syringe.\n\nComputed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.\n\nA small piece of skin removed.\n\nParticipants will be contacted by phone once a year to find out how they are doing.', 'detailedDescription': 'Background:\n\n-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.\n\nObjectives:\n\n* To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.\n* To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.\n* To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.\n\nEligibility:\n\n-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.\n\nDesign:\n\n* Up to 500 subjects will be enrolled.\n* Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.\n* No investigational or experimental therapy will be given as part of this protocol.\n* Re-enrollment will be allowed for a small number of participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be any person over the age of 18 with a diagnosis of cancer or a premalignant disease. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\n 1. Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition\n 2. Age \\>=18 years of age\n 3. ECOG performance status of 0-3.\n\n 5\\. Ability and willingness of subject to provide informed consent\n\nAdditional inclusion criteria pertinent only for participants undergoing apheresis\n\n1. Hemoglobin \\>= 8 mg/dL and platelet count \\> 75 K/microL\n2. Weight \\>= 48 kg\n3. Central line in place or adequate venous access\n\nEXCLUSION CRITERIA:\n\n1. Active concomitant medical or psychological illnesses that may increase the risk to the subject.\n2. Inability to provide informed consent\n3. Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT02682667', 'briefTitle': 'Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols', 'orgStudyIdInfo': {'id': '160061'}, 'secondaryIdInfos': [{'id': '16-C-0061'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1/Cohort 1', 'description': 'Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Scott M Norberg, D.O.', 'role': 'CONTACT', 'email': 'scott.norberg@nih.gov', 'phone': '(301) 275-9668'}], 'overallOfficials': [{'name': 'Scott M Norberg, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data will be shared from the time of upload to dbGaP.', 'ipdSharing': 'YES', 'description': 'All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.', 'accessCriteria': 'Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@@@@@@@Genomic IPD will be shared through dbGaP, per rules of the database, for purposes of genomic analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}