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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0006

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Hepatocellular Carcinoma;
Liver Cancer;
Cholangiocarcinoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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)


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Anuradha Budhu, M.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 37
Room 5046b
37 Convent Drive
Bethesda, Maryland 20892
(240) 760-6837
budhua@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04145141

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