National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer
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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 |
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Recruitment Status :
Recruiting
First Posted : October 30, 2019
Last Update Posted : May 16, 2022
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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 detailed description
| 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 |
| Group/Cohort |
|---|
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1/ Cohort 1
Subjects with a diagnosis or suspicion of PLC
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- 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
- To estimate overall survival following immunotherapy for PLC [ Time Frame: death ]Median amount of time subject survives from the beginning of immunotherapy.
- 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.
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.
| 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 |
- 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)
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
| 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 |
| 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 | |
| Principal Investigator: | Tim F Greten, M.D. | National Cancer Institute (NCI) |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Molecular Markers Predictors for Response or Resistance to Immunotherapy Sample Collection Genetic Analysis Natural History |
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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 |