Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT04972461
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2021-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Response Evaluation by CTC Expansion System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-05', 'size': 391582, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2021-06-09T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Expanded circulating tumor cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To correlate drug sensitivity profiles of the expanded circulating tumor cells with the clinical treatment response.', 'timeFrame': 'CTC was expanded in vitro and drug sensitivity profile to disease-specific panels was obtained. The patient continued with the planned treatment by the treating physician and follow up information was obtained 3 months after blood sampling.', 'description': 'CTC was expanded in vitro culture system and drug sensitivity profile to disease-specific panels was obtained. Clinical treatment response and drug sensitivity profile were analysed with 2 by 2 contingency tables. The evaluation of clinical response rate used by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Briefly, C+ refers to patients with clinical disease control (complete response, partial response, and stable disease), and C- refers to patients were found with worsening diseases (PD). Patients that did not fit into either category were listed as non-evaluable. The drug sensitivity profiles were categorized into E+ and E-. In class E+, at least one chemical in the evaluable treatment regimen was found to kill more than 30% of the cells in the CTC culture system. In class E-, all chemicals in the evaluable treatment regimen were found to kill less than 30% of the cells in the CTC culture system.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Circulating Tumor Cells']}, 'referencesModule': {'references': [{'pmid': '18404148', 'type': 'BACKGROUND', 'citation': 'Pantel K, Brakenhoff RH, Brandt B. Detection, clinical relevance and specific biological properties of disseminating tumour cells. Nat Rev Cancer. 2008 May;8(5):329-40. doi: 10.1038/nrc2375.'}, {'pmid': '22894854', 'type': 'BACKGROUND', 'citation': 'Muller V, Riethdorf S, Rack B, Janni W, Fasching PA, Solomayer E, Aktas B, Kasimir-Bauer S, Pantel K, Fehm T; DETECT study group. Prognostic impact of circulating tumor cells assessed with the CellSearch System and AdnaTest Breast in metastatic breast cancer patients: the DETECT study. Breast Cancer Res. 2012 Aug 15;14(4):R118. doi: 10.1186/bcr3243.'}, {'pmid': '37474689', 'type': 'DERIVED', 'citation': 'Wu YH, Chao HS, Chiang CL, Luo YH, Chiu CH, Yen SH, Liu CY, Chiou JF, Burnouf T, Chen YJ, Wang PY, Chao TY, Hsu SM, Lu LS. Personalized cancer avatars for patients with thymic malignancies: A pilot study with circulating tumor cell-derived organoids. Thorac Cancer. 2023 Sep;14(25):2591-2600. doi: 10.1111/1759-7714.15039. Epub 2023 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'Among biomarkers, CTCs are a convenient, sensitive and biologically informative option. CTC detection could be considered a real-time "liquid biopsy" approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low, so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this study, we develop a short-term CTC expansion protocol combined with a new surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform, which provides an opportunity to monitor response to therapy noninvasively.', 'detailedDescription': 'CTC detection could be considered a real-time "liquid biopsy" approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this proposal we will develop a short-term CTC expansion protocol through combine with a new type of surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform which provide an opportunity to noninvasively monitor response to therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced or metastatic solid tumors were enrolled. Eligible patients were ≥ 20 years old and had a life expectancy of more than 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with malignant tumors\n\nExclusion Criteria:\n\n* Unsuitable for recruitment by clinical judgement or non-compliance with regular follow-up.'}, 'identificationModule': {'nctId': 'NCT04972461', 'briefTitle': 'Therapeutic Response Evaluation by CTC Expansion System', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Hospital'}, 'officialTitle': 'Evaluate the Therapeutic Response by Using in Vitro Circulating Tumor Cell Expansion System', 'orgStudyIdInfo': {'id': 'N201803020'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Long-Sheng Lu, MD, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei Medical University Hospital'}, {'name': 'Jeng-Fong Chiou, MD, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}