Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-04 @ 7:16 AM
Study NCT ID:
NCT04985357
Status:
WITHDRAWN
Last Update Posted:
2024-11-25
First Post:
2021-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D013945', 'term': 'Thymoma'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D008048', 'term': 'Lip Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D010412', 'term': 'Penile Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D001063', 'term': 'Appendiceal Neoplasms'}, {'id': 'D010255', 'term': 'Paranasal Sinus Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D002430', 'term': 'Cecal Neoplasms'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D009669', 'term': 'Nose Neoplasms'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Abandoned prior to launch.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best overall response (BOR)', 'timeFrame': 'up to 24 months', 'description': 'The best overall response to therapy over 24 months will be captured for correlation with test outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage III Breast Cancer', 'Stage IV Breast Cancer', 'Stage III Lung Cancer', 'Stage IV Lung Cancer', 'AML', 'Multiple Myeloma in Relapse', 'Carcinoma', 'Carcinoma, Pancreatic', 'Carcinoma of Lung', 'Carcinoma, Non-Small-Cell Lung', 'Carcinoma Breast', 'Carcinoma Prostate', 'Carcinoma, Hepatocellular', 'Carcinoma, Renal Cell', 'Carcinoma, Neuroendocrine', 'Carcinoma, Small Cell Lung', 'Carcinoma, Ovarian', 'Carcinoma Bladder', 'Carcinoma of Esophagus', 'Carcinoma Cervix', 'Carcinoma, Thymic', 'Carcinoma, Ductal', 'Carcinoma of the Head and Neck', 'Carcinoma of the Lip', 'Carcinoma of the Oral Cavity', 'Carcinoma of Unknown Primary', 'Carcinoma of the Skin', 'Carcinoma of the Anus', 'Carcinoma of the Larynx', 'Carcinoma of the Penis', 'Carcinoma of the Oropharynx', 'Carcinoma of the Appendix', 'Carcinoma of the Paranasal Sinus', 'Carcinoma of the Vulva', 'Malignant Pleural Effusion', 'Malignant Ascites', 'Mesothelioma', 'Cholangiocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.travera.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General population with cohort matched diagnoses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sample collection or biopsy of tumor is clinically indicated as part of SOC\n* Prior to preceding onto therapy for treatment\n\nExclusion Criteria:\n\n* Unable to obtain sufficient sample'}, 'identificationModule': {'nctId': 'NCT04985357', 'briefTitle': 'Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Travera Inc'}, 'officialTitle': 'Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs', 'orgStudyIdInfo': {'id': 'TRV-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carcinoma-Associated Malignant Fluid', 'description': 'Diagnosis of any kind of carcinoma with a malignant fluid (pleural effusion or ascites) where drainage is clinically indicated as part of SOC, and a new course of treatment is upcoming.'}, {'label': 'Carcinoma Solid Tissue Specimen', 'description': 'Diagnosis of any kind of carcinoma where a needle biopsy or tissue resection is clinically indicated as part of SOC, and a new course of treatment is upcoming.'}, {'label': 'Multiple Myeloma', 'description': 'Diagnosis of relapsed multiple myeloma where bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.'}, {'label': 'Acute myelogenous leukemia (AML)', 'description': 'Diagnosis of acute myelogenous leukemia where a blood draw or bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.'}, {'label': 'Triple Negative Breast Cancer (TNBC)', 'description': 'Diagnosis of Stage IV Triple Negative Breast Cancer where a needle biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.'}, {'label': 'Peripheral Blood Cell Immune Competency', 'description': 'Diagnosis of any cancer where a blood draw is clinically indicated as part of SOC, a new course of treatment is upcoming, and checkpoint inhibitor therapy being considered for next line of treatment.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Stevens, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Travera Inc'}, {'name': 'Robert Kimmerling, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Travera Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Travera Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}