- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04410302
Patient-Derived Xenografts to Reduce Cancer Health Disparities
University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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].
II. 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].
III. 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.
IV. 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.
V. 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.
VI. 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.
OUTLINE:
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 deoxyribonucleic acid (DNA) abnormalities to noncancer cells in order to determine if they were present before the cancer started or developed with it.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Recruiting
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Contact:
- Marian Waterman
- Phone Number: 949-824-2885
- Email: marian.waterman@uci.edu
-
Principal Investigator:
- Marian Waterman
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
-
Contact:
- Luis G. Carvajal-Carmona
- Phone Number: 530-752-9654
- Email: lgcarvajal@ucdavis.edu
-
Principal Investigator:
- Luis G. Carvajal-Carmona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient receiving treatment for the above 4 cancers (bladder cancer, lung cancer, gastric/stomach cancer, and liver cancer)
- Signed informed consent that will be put on file
Exclusion Criteria:
- No informed consent obtained
- Specimen unacceptable/degraded/etc.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Adults unable to consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ancillary-correlative (biospecimen collection)
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.
|
Undergo collection of tumor tissue, blood, saliva, and urine samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establish and characterize at least 200 patient-derived cancer xenografts (PDXs)
Time Frame: Up to 4 years
|
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).
|
Up to 4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luis G Carvajal-Carmona, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Neoplasms
- Stomach Neoplasms
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Ductal
Other Study ID Numbers
- 1420270
- P30CA093373 (U.S. NIH Grant/Contract)
- NCI-2020-01323 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 1420270-1 (Other Identifier: University of California Davis Comprehensive Cancer Center)
- U54CA233306 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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