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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT03288168
Eligibility Criteria:
Inclusion Criteria:
* Participants must have classical histology posterior fossa medulloblastoma as determined by institutional neuro-pathological evaluation.
* Participants must have tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for NanoString test for distinguishing the molecular subgroups of medulloblastoma in Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine (SHXH).
* Participants must provide tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for immunohistochemistry assessment in verifying the molecular subgroups of medulloblastoma, or conduct the same immunohistochemistry test according to central analysis in SHXH, and send the slides to SHXH for center reviewing.
* Diagnostic imaging (pre and post operation (OP) contrast MRI or CT, Post-OP imaging conducted within 72 hours, no later than 14 days) must be forwarded to SHXH for central review to confirm eligibility.
* Sufficient pathologic material must be available for central analysis and review in SHXH.
* The patients must have no previous radiotherapy or chemotherapy other than corticosteroids.
* Ability to understand and willingness to comply with follow-up visits.
* Life expectancy more than 4 weeks.
Exclusion Criteria:
* Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.
* Tumor tissue sample not available for biological studies (from the initial diagnosis and/or relapse).
* Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate standard treatment or would likely interfere with study results.
* Patients obtained no radiation and/or chemo therapies are not excluded in this study since the nature history of the disease will also be evaluated.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03288168
Study Brief:
Protocol Section:
NCT03288168