Understanding liver cancer and its treatment options
A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
This study is looking to learn more about liver cancer and its treatments by collecting information from adults with the disease who are getting or planning to get immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | immunotherapy |
| Locations | 7 sites (La Jolla, California and 6 other locations) |
| Trial ID | NCT04145141 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the understanding of primary liver cancer, specifically hepatocellular carcinoma and cholangiocarcinoma, by collecting and analyzing medical records, test results, and biological samples from participants. Individuals aged 18 and older who have liver cancer and have received or plan to receive immunotherapy will be screened and asked about their medical history. The study will gather data on genetic mutations associated with cancer and explore potential treatment options for participants. The goal is to improve clinical management and treatment strategies for liver cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed or suspected liver cancer who have received or are planning to receive immunotherapy.
Not a fit: Patients with known HIV infection may not benefit from this study due to potential confounding factors in the study endpoints.
Why it matters
Potential benefit: If successful, this study could lead to better treatment options and improved outcomes for patients with liver cancer.
How similar studies have performed: Other studies focusing on precision-based immunotherapy for liver cancer have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
La Jolla, California and 6 other locations
- University of California, San Diego (UCSD) — La Jolla, California, United States (Recruiting)
- University of California, San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
- Georgetown University — Washington, District of Columbia, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Tim F Greten, M.D. — National Cancer Institute (NCI)
- Study coordinator: Anuradha Budhu, M.D.
- Email: budhua@mail.nih.gov
- Phone: (240) 760-6837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.