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 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT06215495
Eligibility Criteria:
Inclusion Criteria:
1. High-grade glioma (2021 WHO grade III or IV)
2. Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70
3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential
4. The patient voluntarily joined this study and signed an informed consent form
5. Willing to return for follow-up
6. Willing to provide tissue and blood samples for this research
7. Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)
8. Radiotherapy within 4-6 weeks after surgery
9. No contraindications for taking temozolomide
Exclusion Criteria:
1. Low-grade glioma(2021 WHO grade I or II)
2. had or having other type of malignant cancers
3. not having been performed gross total resection of tumor
4. Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness；
5. Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;
6. Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment)
7. Unable to perform brain magnetic resonance imaging;
8. Allergic to CT contrast agent, unable to perform enhanced CT examination;
9. Remote transfer;
10. Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06215495
Study Brief:
Protocol Section:
NCT06215495