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 @ 12:13 PM
Ignite Modification Date:
2025-12-26 @ 12:13 PM
NCT ID:
NCT04304300
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed glioma, World Health Organisation (WHO) grade 2 or 3, IDH mutated
* Indication for standard treatment with radiotherapy and chemotherapy. For WHO grade 2 tumors 50.4 Gy relative biological equivalent (RBE) in 28 fractions. For WHO grade 3 tumors 59.4 Gy (RBE) in 33 fractions.
* Ability to comply with the protocol, including neuropsychological testing and imaging.
* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.
* Written informed consent.
Exclusion Criteria:
* Any prior chemotherapy for IDHmG. This includes upfront postoperative chemotherapy.
* Any prior cranial radiotherapy, including but not limited to radiotherapy for IDHmG.
* Prior invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with current prostate specific antigen (PSA) of less than or equal to 0.1 ng/mL).
* Extensive white matter disease visible on pre-therapy imaging (Fazekas grade ≥2)
* Contra-indication for magnetic resonance (MR) imaging (i.e. metal implants, claustrophobia)
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule in the participating hospitals
* Any other serious medical condition that could interfere with follow-up.
* Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04304300
Study Brief:
Protocol Section:
NCT04304300