A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
NCT ID: NCT05622409
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2022-12-29
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Arm 1
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.
No interventions assigned to this group
Arm 2
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).
No interventions assigned to this group
Arm 3
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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.
20 Years
ALL
No
Sponsors
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National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Kwang-Yu Chang, MD,PhD
Role: STUDY_CHAIR
National Health Research Institutes, Taiwan
Tsang-Wu Liu, MD
Role: STUDY_CHAIR
National Health Research Institutes, Taiwan
Yong-Kwang Tu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Taipei Neuroscience Institute,Taipei Medical University
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
Taipei, , Taiwan
CHANG GUNG MEMORIAL HOSPITAL, Linkou
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ming-Jung Chuang
Role: primary
Yong-Kwang Tu
Role: primary
Chen-Yuan Lin
Role: primary
Young-sen Yang
Role: primary
Chia-Jui Yen
Role: primary
Dar-Ming Lai
Role: primary
Yao-Yu Hsieh
Role: primary
kuo-chen Wei
Role: primary
Other Identifiers
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T3322
Identifier Type: -
Identifier Source: org_study_id
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