RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-28
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04145141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with histologically/ultrasound/imaging confirmed or suspicious lesions of HCC or CCA.
  2. * Patients with planned or a history of at least 1 dose of immunotherapy for HCC or CCA.
  3. * Ability of subject to understand and the willingness to sign a written informed consent document.
  4. * Age greater than or equal to 18 years old at date of study consent.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Anuradha Budhu, M.D.
CONTACT
(240) 760-6837
budhua@mail.nih.gov
Tim F Greten, M.D.
CONTACT
(240) 760-6114
gretentf@mail.nih.gov

Principal Investigator

Tim F Greten, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

University of California, San Diego (UCSD)
La Jolla, California, 92093
United States
University of California, San Francisco (UCSF)
San Francisco, California, 94143
United States
Georgetown University
Washington, District of Columbia, 20007
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Tim F Greten, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-07-28
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Cholangiocarcinoma