Patient-Derived Xenografts to Reduce Cancer Health Disparities
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04410302|
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment|
|Bladder Carcinoma Gastric Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Lung Carcinoma Malignant Neoplasm||Procedure: Biospecimen Collection|
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.
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 :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities|
|Actual Study Start Date :||November 12, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
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.
Procedure: Biospecimen Collection
Undergo collection of tumor tissue, blood, saliva, and urine samples
- 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).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410302
|United States, California|
|UC Irvine Health/Chao Family Comprehensive Cancer Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Marian Waterman 949-824-2885 firstname.lastname@example.org|
|Principal Investigator: Marian Waterman|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Luis G. Carvajal-Carmona 530-752-9654 email@example.com|
|Principal Investigator: Luis G. Carvajal-Carmona|
|Principal Investigator:||Luis G Carvajal-Carmona||University of California, Davis|