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

NCT04145141 | Active Not Recruiting

• 2 other identifiers: 20000620-C-0006
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatocellular Carcinoma; Liver Cancer; Cholangiocarcinoma

Keywords

Molecular Markers; Predictors for Response or Resistance to Immunotherapy; Sample Collection; Genetic Analysis; Natural History

Outcome Measures

Primary Outcomes (1)

• To establish a biospecimen repository for genomic, genetic and epigenetic analysis to study the biology of PLC development and progression

  Established biospecimen repository for genomic, genetic and epigenetic analysis to study the biology of PLC development and progression

  5 years

Secondary Outcomes (2)

• To estimate overall survival following immunotherapy for PLC

  death

• To estimate 3 years progression-free survival following immunotherapy for PLC

  3 years

Study Arms (1)

1/ Cohort 1

Participants with a diagnosis or suspicion of PLC

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• Participants with histologically/ultrasound/imaging confirmed or suspicious lesions of HCC or CCA.
• Participants with planned or a history of at least 1 dose of immunotherapy for HCC or CCA.
• Ability of individual 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.

You may not qualify if:

• Participants with known HIV infection (as these individuals may have abnormal test results which may confound the endpoints of this study)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Tim F Greten, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 30, 2019
• Study Start: July 28, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (4)