Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT02555735
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-02-01
First Post:
2015-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exceptional Responders With Solid Tumor Cancer to Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify exceptional responders with cancer to standard of care chemotherapy', 'timeFrame': '9 years', 'description': 'Identify responders and non-responders'}], 'secondaryOutcomes': [{'measure': 'Correlation of genomic profiles from circulating cells with overall survival', 'timeFrame': '9 years', 'description': 'Genomic expression profiles correlated with progression free and overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Solid Tumor cancer'], 'conditions': ['Solid Tumor Neoplasms']}, 'referencesModule': {'references': [{'pmid': '30477242', 'type': 'BACKGROUND', 'citation': "Yu KH, Ricigliano M, McCarthy B, Chou JF, Capanu M, Cooper B, Bartlett A, Covington C, Lowery MA, O'Reilly EM. Circulating Tumor and Invasive Cell Gene Expression Profile Predicts Treatment Response and Survival in Pancreatic Adenocarcinoma. Cancers (Basel). 2018 Nov 24;10(12):467. doi: 10.3390/cancers10120467."}, {'pmid': '35740571', 'type': 'BACKGROUND', 'citation': 'Isacoff WH, Cooper B, Bartlett A, McCarthy B, Yu KH. ChemoSensitivity Assay Guided Metronomic Chemotherapy Is Safe and Effective for Treating Advanced Pancreatic Cancer. Cancers (Basel). 2022 Jun 13;14(12):2906. doi: 10.3390/cancers14122906.'}, {'pmid': '35647938', 'type': 'BACKGROUND', 'citation': "Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1."}]}, 'descriptionModule': {'briefSummary': 'This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.', 'detailedDescription': 'This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with solid tumor cancers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological confirmation of solid tumor carcinoma.\n* Patient is treatment-naïve or currently receiving chemotherapy.\n* ECOG performance status (any).\n\nExclusion Criteria:\n\n* HIV positive on antiretroviral therapy\n* Pregnant or lactating\n* Prior organ allograft\n* Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment'}, 'identificationModule': {'nctId': 'NCT02555735', 'briefTitle': 'Exceptional Responders With Solid Tumor Cancer to Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adera Labs, LLC'}, 'officialTitle': 'Evaluation of Exceptional Responders With Solid Tumor Cancer', 'orgStudyIdInfo': {'id': 'ADRL-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Solid Tumor Cancer', 'description': 'Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy.', 'interventionNames': ['Drug: Standard of Care Chemotherapy']}], 'interventions': [{'name': 'Standard of Care Chemotherapy', 'type': 'DRUG', 'description': "Physician's Choice Chemotherapy Treatment (non-guided)", 'armGroupLabels': ['Solid Tumor Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Pancreatic Cancer Treatment Center of Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Brian McCarthy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adera Labs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adera Labs, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Pancreatic Cancer Treatment Center of Los Angeles', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}