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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 : June 1, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment
Bladder Carcinoma Gastric Carcinoma Liver and Intrahepatic Bile Duct Carcinoma Lung Carcinoma Malignant Neoplasm Procedure: Biospecimen Collection

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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


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.
Procedure: Biospecimen Collection
Undergo collection of tumor tissue, blood, saliva, and urine samples




Primary Outcome Measures :
  1. 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
Tumor tissue, blood, saliva, urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
UC Irvine Health/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Marian Waterman    949-824-2885    marian.waterman@uci.edu   
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    lgcarvajal@ucdavis.edu   
Principal Investigator: Luis G. Carvajal-Carmona         
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Luis G Carvajal-Carmona University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04410302    
Other Study ID Numbers: 1420270
NCI-2020-01323 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1420270-1 ( Other Identifier: University of California Davis Comprehensive Cancer Center )
P30CA093373 ( U.S. NIH Grant/Contract )
U54CA233306 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Stomach Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Ductal
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary