Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-04 @ 7:56 PM
Study NCT ID:
NCT02688894
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue, whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 797}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-29', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of each molecular subtypes', 'timeFrame': 'After registration of this study', 'description': 'To provide molecular characteristics of SCLC to proceed SUKSES trial'}], 'secondaryOutcomes': [{'measure': 'Success rate of each molecular profiling methods', 'timeFrame': 'After completion of registration', 'description': 'To provide molecular characteristics of SCLC to proceed SUKSES trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancers', 'Neuroendocrine Carcinoma']}, 'descriptionModule': {'briefSummary': 'This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.\n\nThis procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.\n\nImmunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.\n\nTumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.\n\nSpecific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.', 'detailedDescription': 'This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.\n\nThis procedure (molecular profiling) can be performed before, during, or after the initial treatment.\n\nDNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.\n\nImmunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.\n\nIn addition, blood collection will be conducted at Baseline (initial), three weeks, six weeks, twelve weeks, and subsequent imaging.\n\nTumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Histologically or cytologically confirmed Small cell lung cancers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of fully informed consent prior to any study specific procedures.\n2. Patients must be ≥20 years of age.\n3. Histologically or cytologically confirmed Small cell lung cancers\n4. ECOG performance status of 0 to 2\n5. Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment\n6. Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis\n\nExclusion Criteria:\n\n1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer\n2. Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)\n3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.'}, 'identificationModule': {'nctId': 'NCT02688894', 'briefTitle': 'The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]', 'orgStudyIdInfo': {'id': '2016-02-071'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Small cell lung cancers', 'description': 'To provide molecular characteristics of Small cell lung cancers to proceed SUKSES trial, To assess success rate of molecular profiling of Small cell lung cancers', 'interventionNames': ['Other: No treatment is included in this protocol.']}], 'interventions': [{'name': 'No treatment is included in this protocol.', 'type': 'OTHER', 'description': 'Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.\n\nSpecific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.', 'armGroupLabels': ['Small cell lung cancers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jungbuk', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Chungbuk University Hospital', 'geoPoint': {'lat': 35.55292, 'lon': 127.49042}}, {'city': 'Seongnam', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Se-Hoon Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'sehoon.lee@samsung.com', 'phone': '82-2-2148-7665'}, {'name': 'Se-Hoon Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'VHS Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'centralContacts': [{'name': 'Se-Hoon Lee, MD,Ph.D.', 'role': 'CONTACT', 'email': 'sehoon.lee@samsung.com', 'phone': '+82-10-4759-7640'}, {'name': 'Seoha Kim', 'role': 'CONTACT', 'email': 'seoha88.kim@samsung.com', 'phone': '+82-2-2148-7668'}], 'overallOfficials': [{'name': 'Se-Hoon Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Se-Hoon Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}