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ACTIVE NOT RECRUITING
NCT03278925
PHASE1

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: A Phase I Single-arm, Multicenter Pilot Study Aimed at Validating γ-OHPdG as a Biomarker and Testing the Effects of Polyphenon E on Its Levels in Patients With Cirrhosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2018-08-09

Completion Date

2024-12-31

Last Updated

2024-08-02

Healthy Volunteers

No

Conditions

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

Locations (2)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Puerto Rico

San Juan, Puerto Rico