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:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT05124951
Eligibility Criteria:
Stratum I: germinoma
Inclusion Criteria:
* 3 years ≤ age ≤ 30 years
* Newly diagnosed
* Unilateral basal ganglia/thalamus lesion
* Germinoma：Histologically confirmed; and/or serum and/or CSF beta-HCG elevation (≤50IU/L); AFP negative
* No radiological evidence of additional lesions in the CNS
* Negative CSF cytology test
* Adequate organ function
* Written informed consent
Exclusion Criteria:
* Bilateral basal ganglia/ thalamus lesions
* Synchronous pineal or sellar/suprasellar lesion
* Diabetes insipidus
* With extracranial lesion(s)
* Serum/CSF β-HCG \>50IU/L without histology
* Mature teratoma with normal tumor markers
* Inadequate organ function
* Poor compliance
Stratum II: non-germinomatous germ cell tumors
Inclusion Criteria:
* 3 years ≤ age ≤ 30 years
* Newly diagnosed
* Unilateral basal ganglia/thalamus lesion
* NGGCTs: Histologically confirmed; and/or serum and/or CSF AFP elevation; beta-HCG≥500IU/L
* No radiological evidence of additional lesions in the CNS
* Negative CSF cytology test
* Adequate organ function
* Written informed consent
Exclusion Criteria:
* Bilateral basal ganglia/ thalamus lesions
* Synchronous pineal or sellar/suprasellar lesion
* Diabetes insipitus
* With extracranial lesion(s)
* 50IU/L\<serum/CSF β-HCG \<500IU/L without histology
* Mature teratoma with normal AFP and β-HCG \<500IU/L
* Inadequate organ function
* Poor compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
30 Years
Study:
NCT05124951
Study Brief:
Protocol Section:
NCT05124951