Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-06 @ 1:13 PM
Study NCT ID:
NCT02515760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-12
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor-specific T Cells in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-08', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequencies of tumor-specific T cells', 'timeFrame': '2 weeks postoperative', 'description': '% of all T cells'}], 'secondaryOutcomes': [{'measure': 'Tumor-specific T cells location determined by Enzyme Linked Immuno Spot Assay (ELISPOT) analysis of peripheral blood and bone marrow samples from the same patient', 'timeFrame': '2 weeks postoperative', 'description': 'location: peripheral versus bone marrow'}, {'measure': 'Long-term survival', 'timeFrame': '5 years postoperative', 'description': 'OS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '29617574', 'type': 'BACKGROUND', 'citation': 'Yamauchi Y, Safi S, Blattner C, Rathinasamy A, Umansky L, Juenger S, Warth A, Eichhorn M, Muley T, Herth FJF, Dienemann H, Platten M, Beckhove P, Utikal J, Hoffmann H, Umansky V. Circulating and Tumor Myeloid-derived Suppressor Cells in Resectable Non-Small Cell Lung Cancer. Am J Respir Crit Care Med. 2018 Sep 15;198(6):777-787. doi: 10.1164/rccm.201708-1707OC.'}, {'pmid': '33255425', 'type': 'RESULT', 'citation': 'Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung Cancer. Cancers (Basel). 2020 Nov 24;12(12):3496. doi: 10.3390/cancers12123496.'}, {'pmid': '31741774', 'type': 'RESULT', 'citation': 'Safi S, Yamauchi Y, Stamova S, Rathinasamy A, Op den Winkel J, Junger S, Bucur M, Umansky L, Warth A, Herpel E, Eichhorn M, Winter H, Hoffmann H, Beckhove P. Bone marrow expands the repertoire of functional T cells targeting tumor-associated antigens in patients with resectable non-small-cell lung cancer. Oncoimmunology. 2019 Oct 23;8(12):e1671762. doi: 10.1080/2162402X.2019.1671762. eCollection 2019.'}, {'pmid': '29147626', 'type': 'RESULT', 'citation': 'Safi S, Yamauchi Y, Rathinasamy A, Stamova S, Eichhorn M, Warth A, Rauch G, Dienemann H, Hoffmann H, Beckhove P. Functional T cells targeting tumor-associated antigens are predictive for recurrence-free survival of patients with radically operated non-small cell lung cancer. Oncoimmunology. 2017 Sep 8;6(11):e1360458. doi: 10.1080/2162402X.2017.1360458. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)\n* Healthy donors (control group)\n* written informed consent\n\nExclusion Criteria:\n\n* Autoimmune disease\n* Patients receiving immunomodulatory drugs, e.g. tacrolimus\n* Prior malignancy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02515760', 'briefTitle': 'Tumor-specific T Cells in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Tumor-specific Effector T Cells in Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'S-515/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung cancer group', 'description': 'Bone marrow puncture in patients with non-small cell lung cancer', 'interventionNames': ['Procedure: Bone marrow aspiration from the iliac crest', 'Device: Illinois bone marrow aspiration neddle']}, {'type': 'EXPERIMENTAL', 'label': 'Control group (healthy donors)', 'description': 'Bone marrow puncture in healthy donors', 'interventionNames': ['Procedure: Bone marrow aspiration from the iliac crest', 'Device: Illinois bone marrow aspiration neddle']}], 'interventions': [{'name': 'Bone marrow aspiration from the iliac crest', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group (healthy donors)', 'Lung cancer group']}, {'name': 'Illinois bone marrow aspiration neddle', 'type': 'DEVICE', 'armGroupLabels': ['Control group (healthy donors)', 'Lung cancer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Division of Thoracic Surgery, Technical University of Munich, Munich, Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Seyer Safi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division Thoracic Surgery, Technical University of Munich, Munich, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Research Center', 'class': 'OTHER'}, {'name': 'Heidelberg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Seyer Safi', 'investigatorFullName': 'Dr. med. Seyer Safi', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}