Patient-Derived Xenografts to Reduce Cancer Health Disparities

NCT04410302 | Unknown FDA Drug

• 5 other identifiers: 1420270NCI-2020-013231420270-1P30CA093373U54CA233306
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Carcinoma; Gastric Carcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Lung Carcinoma; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 4 years

Study Arms (1)

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

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of tumor tissue, blood, saliva, and urine samples

Ancillary-correlative (biospecimen collection)

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• No informed consent obtained
• Specimen unacceptable/degraded/etc.
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Adults unable to consent

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, blood, saliva, urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Stomach Neoplasms; Carcinoma, Hepatocellular; Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Luis G Carvajal-Carmona

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: November 12, 2019
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (2)