RecruitingNCT04145141

National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer

A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)


Sponsor

National Cancer Institute (NCI)

Enrollment

500 participants

Start Date

Jul 28, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Primary Liver Cancer is the second most common cause of cancer-related death worldwide. It is the cancer with the fastest rising incidence and mortality in the United States. Researchers want to learn more about liver cancer to help them design better treatments. Objective: To better understand liver cancer. Eligibility: People ages 18 and older who have liver cancer and had or are planning to have immune therapy Design: Participants will be screened with a review of their medical records. They will be asked about their medical history and test results. Participants will come to the NIH Clinical Center. During this visit, their medical records, test results, imaging studies, and tissue samples (if available) will be gathered. Participants will learn the results of a test to see if they have any mutations known to be connected to cancer. They will learn if there are treatment options for them. Participants will give blood, urine, and stool samples or rectal swabs. Participants will not have follow-up visits just for this study. If they join another NIH research study and have visits for this other study, their medical records; test results; and blood, urine, and stool samples may be collected. This will occur about every 3 months. If they have a biopsy or surgery on another study or as part of treatment and there is leftover tissue, researchers would like to collect some of that tissue. Participants will be contacted every 6 months by phone or e-mail. They will be asked about their health. They will provide any medical records, test results, and imaging studies. Participants will be followed on this study for life.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria4

  • Patients with histologically/ultrasound/imaging confirmed or suspicious lesions of HCC or CCA.
  • Patients with planned or a history of at least 1 dose of immunotherapy for HCC or CCA.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Age greater than or equal to 18 years old at date of study consent.

Exclusion Criteria1

  • \- Patients with known HIV infection (as these patients may have abnormal test results which may confound the endpoints of this study)

Locations(7)

University of California, San Diego (UCSD)

La Jolla, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT04145141


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