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Defined Green Tea Catechin Extract in Preventing Liver Cancer in Participants With Cirrhosis

NCT03278925 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-08-02

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of defined green tea catechin extract and to see how well it works in preventing liver cancer in participants with cirrhosis. Higher levels of the molecule gamma-OHPdG may be found in participants with cirrhosis, which may mean a higher risk of the development of liver cancer. Defined green tea catechin extract may work better to lower levels of gamma-OHPdG and prevent the development of liver cancer.

Conditions

  • Cirrhosis

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Defined Green Tea Catechin Extract

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Pharmacological Study

Correlative studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Ultrasound

Undergo ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Aiwu R He · Northwestern University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2023-06-16
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278925 on ClinicalTrials.gov