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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT00003912
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven hepatoblastoma or hepatocellular carcinoma
* Diagnostic surgical biopsy strongly recommended for all patients and mandatory for the following:
* Children under 6 months of age
* Children over 3 years of age
* Patients with a normal serum alfa-fetoprotein (alfa-FP)
* Compatible imaging and raised serum alfa-FP level mandatory if no biopsy performed
* Standard risk disease:
* Tumors involving no more than 3 hepatic sections
* No extrahepatic abdominal disease
* No metastases
* High risk disease:
* Tumors involving all 4 hepatic sections AND/OR
* Evidence of extrahepatic metastases or abdominal disease
* Presence or absence of metastatic disease must be documented by chest x-ray and/or lung CT scan
PATIENT CHARACTERISTICS:
Age:
* 16 and under at diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
* Prior surgery allowed
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
16 Years
Study:
NCT00003912
Study Brief:
Protocol Section:
NCT00003912