Registry study for genetic profiling of adult-type diffuse gliomas in Taiwan
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
This study is trying to create a detailed database of genetic information about adult brain tumors in Taiwan to see how this information can improve treatment and outcomes for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 8 sites (Kaohsiung City and 7 other locations) |
| Trial ID | NCT05622409 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a comprehensive registry for adult-type diffuse gliomas in Taiwan, focusing on their genetic and molecular profiles through next-generation sequencing. The study will analyze the impact of these profiles on treatment outcomes and disease progression. By collecting and storing clinical data alongside tumor samples, the research seeks to enhance personalized therapy and develop novel treatment strategies for patients suffering from these aggressive brain tumors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with a confirmed or suspected diagnosis of adult-type diffuse gliomas, such as glioblastoma or astrocytoma.
Not a fit: Patients with non-diffuse gliomas or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with adult-type diffuse gliomas.
How similar studies have performed: While this approach is innovative in the context of Taiwan, similar studies in other regions have shown promise in utilizing genetic profiling for glioma treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Willingness to provide archival or newly obtained tumor tissues for current study proposal. 3. Age equal or more than 20 years old (inform consent). 4. Life expectancy more than 3 months. 5. Patients fully understand the protocol with the willingness to have regular follow-up. 6. Additional criteria for individual arms A. \[Arm 1\] Within 2 months after surgery for primary tumor. B. \[Arm 2\] Total resection of primary tumors with tissue samples available for test. 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: 1. Gliomas diagnosed or preferred as other categories than ATDGs, such as pediatric-type diffuse gliomas, circumscribed astrocytic gliomas, and others. 2. Inability to cooperate by providing a complete medical history. 3. Patients disagree to provide archived tumor samples. 4. Undesirable compliance. 5. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
Where this trial is running
Kaohsiung City and 7 other locations
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- Shuang Ho Hospital — New Taipei City, Taiwan (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital — Taipei, Taiwan (Recruiting)
- CHANG GUNG MEMORIAL HOSPITAL, Linkou — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yong-Kwang Tu, MD, PhD — Taipei Neuroscience Institute,Taipei Medical University
- Study coordinator: Chien-Ya Hung
- Email: 951106@nhri.edu.tw
- Phone: +886-3-7206166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.