Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT04410302
Status:
UNKNOWN
Last Update Posted:
2023-10-16
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-Derived Xenografts to Reduce Cancer Health Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue, blood, saliva, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish and characterize at least 200 patient-derived cancer xenografts (PDXs)', 'timeFrame': 'Up to 4 years', 'description': 'The investigators will establish and characterize at least 200 PDXs, and utilize these PDXs in preclinicial testing of single agents and drug combinations that help guide future clinical decision-making emphasizing the largest racial/ethnic minority populations residing in California: Hispanic/Latino Americans (\\[HLAs), Asian Americans/Native Hawaiians/Pacific Islanders (AANHIPIs), and African Americans (AAs) compared to Non-Hispanic Whites (NHWs).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Carcinoma', 'Gastric Carcinoma', 'Liver and Intrahepatic Bile Duct Carcinoma', 'Lung Carcinoma', 'Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This trial establishes patient-derived cancer xenografts in addressing cancer health and treatment disparities that disproportionately affect racial/ethnic minorities. Understanding the genetic and response differences among racial/ethnic minorities may help researchers enhance the precision of therapeutic treatments.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Develop and characterize over 200 patient-derived xenografts (PDXs), with at least 50 PDXs each for gastric, liver, bladder, and lung cancers with 60% (approximately) of the PDXs from minority patients, focusing on Hispanic/Latino Americans \\[HLAs\\], African Americans \\[AAs\\], and Asian American/Native Hawaiians/Pacific Islanders \\[AANHPIs\\].\n\nII. Utilize these PDXs in preclinical testing of single agents and drug combinations to guide precision cancer medicine decision-making with a focus upon the predominant racial/ethnic minority populations residing in California compared to non-Hispanic Whites \\[NHWs\\].\n\nIII. Conduct "Characterizing Treatment Responses with PDX Models for Gastric and Liver Tumors" as Research Project 1, focused on the most common histological forms of gastric cancer (GC) and liver cancers (LC) primarily from HLAs and AANHPI patients.\n\nIV. Conduct "Characterizing Treatment Responses with PDX Models for Lung and Bladder Tumors" as Research Project 2, focused on lung squamous cell carcinoma (LSCC) and advanced urothelial or bladder cancer (aBC) primarily from AA and NHW patients.\n\nV. Collaborate with the National Cancer Institute (NCI), other PDX Development and Trial Centers (PDTCs), non-PDXNet, PDXNet Data Commons and Coordinating Centers to fulfill the mission of the PDXNet.\n\nVI. Select and conduct pilot projects through the Pilot Projects and Trans-Network Activities Core (PPTNAC) inclusive of UCaMP members, other PDTCs and beyond that will evaluate comparative therapeutic responses using PDX models and contribute to the elucidation of biological determinants of cancer health disparities in gastric, liver, bladder, and lung cancers.\n\nOUTLINE:\n\nPatients undergo collection of tumor tissue samples during standard of care tumor biopsy or surgical resection to establish PDXs. Patients may also undergo collection of blood, saliva, and urine samples to compare deoxyribonucleic acid (DNA) abnormalities to noncancer cells in order to determine if they were present before the cancer started or developed with it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with bladder cancer, lung cancer, gastric/stomach cancer, or liver cancer seen in routine clinic appointments within the University of California (UC) Davis Health System and contributing University of California Minority PDX (UCaMP) institutions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient receiving treatment for the above 4 cancers (bladder cancer, lung cancer, gastric/stomach cancer, and liver cancer)\n* Signed informed consent that will be put on file\n\nExclusion Criteria:\n\n* No informed consent obtained\n* Specimen unacceptable/degraded/etc.\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners\n* Adults unable to consent'}, 'identificationModule': {'nctId': 'NCT04410302', 'briefTitle': 'Patient-Derived Xenografts to Reduce Cancer Health Disparities', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities', 'orgStudyIdInfo': {'id': '1420270'}, 'secondaryIdInfos': [{'id': 'NCI-2020-01323', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '1420270-1', 'type': 'OTHER', 'domain': 'University of California Davis Comprehensive Cancer Center'}, {'id': 'P30CA093373', 'link': 'https://reporter.nih.gov/quickSearch/P30CA093373', 'type': 'NIH'}, {'id': 'U54CA233306', 'link': 'https://reporter.nih.gov/quickSearch/U54CA233306', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-correlative (biospecimen collection)', 'description': 'Patients undergo collection of tumor tissue samples during standard of care tumor biopsy or surgical resection to establish PDXs. Patients may also undergo collection of blood, saliva, and urine samples to compare DNA abnormalities to noncancer cells in order to determine if they were present before the cancer started or developed with it.', 'interventionNames': ['Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of tumor tissue, blood, saliva, and urine samples', 'armGroupLabels': ['Ancillary-correlative (biospecimen collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marian Waterman', 'role': 'CONTACT', 'email': 'marian.waterman@uci.edu', 'phone': '949-824-2885'}, {'name': 'Marian Waterman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luis G. Carvajal-Carmona', 'role': 'CONTACT', 'email': 'lgcarvajal@ucdavis.edu', 'phone': '530-752-9654'}, {'name': 'Luis G. Carvajal-Carmona', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Luis G Carvajal-Carmona', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}