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 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT02209428
Eligibility Criteria:
Inclusion Criteria:
* 18 years \< age ≤ 40 years, both genders.
* No neurologic cognitive deficits (MMSE ≥ 27), no psychiatric abnormalities before surgery, pre-operative KPS ≥ 80.
* Tumors located in eloquent areas or deeply located nuclei, rendering radiological complete resection inapplicable, according to updated standards of extent of resection: as for non-enhancing LGG, postoperative MRI within 72h shows absence of any preoperative T2/FLAIR signal changes - complete resection; and for enhancing LGG, postoperative MRI shows total removal of preoperative enhancing tissue - complete resection of enhancing tumor; and total removal of enhancing and non-enhancing tissues (T2/FLAIR) - complete resection of detectable tumor.
* Post-operative histological pathology confirms LGGs (astrocytomas, oligodendrogliomas, or oligoastrocytomas, 2007 WHO classification Grade II).
* No contraindications to TMZ chemotherapy.
* Informed consent to TMZ chemotherapy.
Exclusion Criteria:
* Tumor involves more than 3 cerebral lobes (gliomatosis or multiple gliomas).
* Tumor is complicated with other intracranial neoplasms (e.g. metastatic tumors or meningiomas).
* Tumor is complicated with systematic malignancies.
* Dysfunctions of other vital organs: liver and kidney (ALT﹥40U/L, AST \> 40U/L, creatinine \> 97-106μmol/L, urea nitrogen \> 7.1mmol/L, or other lab abnormalities); Heart (NYHA II-IV); Lungs (hypoxemia).
* Physiological pregnancy.
* Participate in other clinical trials at meantime.
* History of severe anaphylaxis.
* Voluntarily quit or decline chemotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02209428
Study Brief:
Protocol Section:
NCT02209428