Bladder CarcinomaNCT04410302
Patient-Derived Xenografts to Reduce Cancer Health Disparities
An observational study of Bladder Carcinoma and Gastric Carcinoma, run by University of California, Davis at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Bladder Carcinoma, Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2019to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- No informed consent obtained
- Specimen unacceptable/degraded/etc.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Adults unable to consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Marian Waterman, 949-824-2885, marian.waterman@uci.edu
Marian Waterman
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Luis G. Carvajal-Carmona, 530-752-9654, lgcarvajal@ucdavis.edu
Luis G. Carvajal-Carmona
About this study
Official title: University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Bladder Carcinoma, Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Lung Carcinoma, Malignant Neoplasm
- Being tested
- Biospecimen Collection
- Medical subject headings
- Urinary Bladder Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of tumor tissue, blood, saliva, and urine samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish and characterize at least 200 patient-derived cancer xenografts (PDXs)
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).
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start12 Nov 2019
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Luis G Carvajal-Carmona, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410302
- Sponsor's protocol ID
- 1420270
- Other IDs
- NCI-2020-01323, 1420270-1, P30CA093373, U54CA233306
- Status last verified
- Jul 2026
- First submitted
- 27 May 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities
- ClinicalTrials.gov ID
- NCT04410302
- Acronym / sponsor ID
- 1420270
- Conditions
- Bladder Carcinoma, Gastric Carcinoma, Liver and Intrahepatic Bile Duct Carcinoma, Lung Carcinoma, Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | – | Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- No informed consent obtained
- Specimen unacceptable/degraded/etc.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of tumor tissue, blood, saliva, and urine samples | Procedure or surgery | Ancillary-correlative (biospecimen collection) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis G Carvajal-Carmona principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Carcinoma and Gastric Carcinoma, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asst. Clinical Research Coordinator (916-734-1587, tfle@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish and characterize at least 200 patient-derived cancer xenografts (PDXs) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.