Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04145141
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Hepatocellular Carcinoma Liver Cancer Cholangiocarcinoma

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Group/Cohort
1/ Cohort 1
Subjects with a diagnosis or suspicion of PLC



Primary Outcome Measures :
  1. To establish a biospecimen repository for genomic, genetic and epigenetic analysis to study the biology of PLC development and progression [ Time Frame: 5 years ]
    Established biospecimen repository for genomic, genetic and epigenetic analysis to study the biology of PLC development and progression


Secondary Outcome Measures :
  1. To estimate overall survival following immunotherapy for PLC [ Time Frame: death ]
    Median amount of time subject survives from the beginning of immunotherapy.

  2. To estimate 3 years progression-free survival following immunotherapy for PLC [ Time Frame: 3 years ]
    Proportion of patients that have progressive disease after 3 years.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinical
Criteria
  • INCLUSION CRITERIA:
  • 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 CRITERIA:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145141


Contacts
Layout table for location contacts
Contact: Anuradha Budhu, M.D. (240) 760-6837 budhua@mail.nih.gov
Contact: Tim F Greten, M.D. (240) 760-6114 gretentf@mail.nih.gov

Locations
Layout table for location information
United States, California
University of California (UCSD) Recruiting
San Diego, California, United States, 92093
Contact: Adam Burgoyne    858-246-0674    aburgoyne@health.ucsd.edu   
University of California (UCSF) Recruiting
San Francisco, California, United States, 94158
Contact: Robin Katie Kelley    415-353-7065    katie.kelly@ucsf.edu   
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007-2197
Contact: Ruth He    202-444-2223    arh29@georgetown.edu   
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Ghassan Abou-Alfa    646-888-4184    abou-alg@mskcc.org   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107-6541
Contact: Hien Dang, PhD    215-955-1621    Hien.Dang@jefferson.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Yujin Hoshida, PhD    214-648-6137    yujin.hoshida@utsouthwestern.edu   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Tim F Greten, M.D. National Cancer Institute (NCI)
Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04145141    
Other Study ID Numbers: 200006
20-C-0006
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: April 7, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Molecular Markers
Predictors for Response or Resistance to Immunotherapy
Sample Collection
Genetic Analysis
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases