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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT03877861
Eligibility Criteria:
Inclusion Criteria
i. Patients aged between 22 and 70. ii. Patients must have a histologic diagnosis of primary Grade IV glioma. iii. Patients must have received maximal debulking surgery and radiotherapy concomitant with Temozolomide (≥ 75% of their recommended temozolomide dosage is required).
iv. Patients with KPS ≥70. v. Life expectancy at least 3 months. vi. Patients must have signed informed consent for study participation. vii. Patients should be English speakers.
Exclusion Criteria
i. Patients enrolled in active clinical treatment trials for primary Grade IV glioma.
ii. Patients with progressive disease after completion of radiotherapy concomitant with Temozolomide as per RANO criteria. Suspected pseudoprogression should be confirmed by additional imaging studies ordered as part of standard care.
iii. Patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies).
iv. Patients who are pregnant or trying to get pregnant. v. Patients unable to wear the ReadiBand device continuously during study duration.
vi. Patients with infra-tentorial tumors. vii. Patients with known psychiatric concerns. viii. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
1. Thrombocytopenia (platelet count \< 100 x 103/μL)
2. Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
4. Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
5. Total bilirubin \> upper limit of normal, if clinically significant
6. Significant renal impairment (serum creatinine \> 1.7 mg/dL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
70 Years
Study:
NCT03877861
Study Brief:
Protocol Section:
NCT03877861