Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00276705
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed hepatocellular carcinoma (HCC) family of tumors by percutaneous needle biopsy (unless primary tumor resection is attempted)
* Newly diagnosed disease
* No recurrent disease
* Fibrolamellar and transitional variants
* Noncirrhotic disease
* If suspicious of liver cirrhosis (e.g., abnormal liver function tests and/or positive viral serology and/or radiological evidence) at diagnosis, patient must undergo biopsy of normal liver to exclude liver cirrhosis
PATIENT CHARACTERISTICS:
* Able to follow the protocol
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Life expectancy at least 3 months
* Glomerular filtration rate ≥ 75-50% of the lower limit of normal for age (≥ 60 mL/min for patients ≥ 2 years old)
* Cardiac ejection fraction ≥ 29% at baseline ECHO
PRIOR CONCURRENT THERAPY:
* No prior treatment for HCC
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
29 Years
Study:
NCT00276705
Study Brief:
Protocol Section:
NCT00276705