An observational study in Primary Malignant Brain Tumors, sponsored by National Health Research Institutes, Taiwan. Recruiting at 8 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by National Health Research Institutes, Taiwan · Observational
Glioma is a major histological subtype of primary malignant brain tumors in Taiwan, with distinct epidemiological, clinical, and pathological features comparing to the other common cancer diseases. The disease rarely appears with metastatic disease at diagnosis, and with the most malignant subtype, glioblastoma, occurs with preference in mid- to old-age. For decades, primary malignant brain tumors has been known as one of the most desperate disease without successful improvement regarding of the treatment. Surgical resection is the principle for the primary treatment of gliomas. Chemotherapy and radiotherapy are often applied to patients for adjuvant therapy of surgery to pursue the treatment effect. Disappointedly, vast majority of the patients would eventually develop disease recurrence, leaving only limited choice for salvage treatment thereafter. The prognosis of these patients remains desperate, and thus a better understanding of this deadly disease is crucial for finding better therapeutic strategies for these patients.
With demand of molecular characterization in precise diagnosis, we proposed this registry study to explore the impact of the new criteria by applying next-generation sequencing. The specific aims of this project are (1) to establish the tumor genetic and molecular profiles of adult-type diffuse gliomas in Taiwan, (2) to understand the treatment prognosis depending on difference of the genetic and molecular profiles for adult-type diffuse gliomas in Taiwan, and (3) to reveal the evolutionary changes of genetic and molecular features of adult-type diffuse gliomas. The long-term goals of this study are to help implement personalized therapy, to develop novel therapy, and to improve outcomes of patients with adult-type diffuse gliomas. It is also expected to create a platform for data storage and sharing.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →National Health Research Institutes, Taiwan is the lead sponsor of 125 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Arm 1: (Newly diagnosis arm): Anticipated 100 patients. Arm 2: IDH expression (N=83 for IDH-mutant and N=82 for IDH-wild type) Arm 3:Recurrent and paired samples (N=10).
Pathological confirmation or suggestion of adult-type diffuse gliomas A. Diagnosis includes glioblastoma, astrocytoma, oligodendrocytoma that is listed in ATDG category per WHO criteria.
B. Gliomas that are preferred as ATDGs from pathological and clinical views, but not given for confirmed diagnosis.
C. [Arm 3] (1) Total resection of primary tumors with the paired primary and recurrent tissue samples available for test. (2) IDH test suggesting wild-type.
Exclusion Criteria:
Newly diagnosis arm (N=150): The study aims to obtain clinical information to correlate with genetic characterization of ATDGs of all types. Only patients with primary tumors that have recently received surgery are applicable.
Post treatment arm 1 for training set (IDH-wild type ATDGs, N=50; IDH-mutant ATDGs, N=50): The study aims to compare the genetic differences of ATDGs in terms of IDH mutation status. Samples of primary tumors are preferred but can be replaced with recurrent ones. Paired samples are both eligible for typing if the recurrent diseases of IDH-mutant tumors possess potential altered genes (such as up grading per histology features).
Post treatment arm 2 (recurrent ATDGs; N=25): The study will focus on recurrent diseases of ATDGs to study the consistency of genetic difference of the primary and the recurrent tumors. Tumor free is mandatory and needs to be documented after resection of the primary tumor. Patients remain eligible if IDH statuses are uncertain.
To evaluate the genetic profiles in brain tumor patients in Taiwan.
ACTonco+ACTFusion Biospecimen Retention: Samples With DNA One H\&E staining slide, and 15-20 tissue slides (5 um thickness) for cancer panel. Details of Tests/Collaborative Test Unit: Testing will take place in a certified precision medicine laboratory. Non-tumor Sample (Blood): Seven(7)ml of cell free DNA and Eight (8) ml of blood in EDTA tube will be collected from the participant
Time frame: 5 years
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National Health Research Institutes, Taiwan