Primary Malignant Brain TumorsNCT05622409
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
An observational study of Primary Malignant Brain Tumors, run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Malignant Brain Tumors
- How many people
- 250 participants
- Where
- 8 sitesTaiwan
- Study dates
- 29 Dec 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: 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).
Who may be able to join
- Pathological confirmation or suggestion of adult-type diffuse gliomas A. Diagnosis includes glioblastoma, astrocytoma, oligodendrocytoma that is listed in ATDG category per WHO criteria.
- Gliomas that are preferred as ATDGs from pathological and clinical views, but not given for confirmed diagnosis.
- Willingness to provide archival or newly obtained tumor tissues for current study proposal.
- Age equal or more than 20 years old (inform consent).
- Life expectancy more than 3 months.
- Patients fully understand the protocol with the willingness to have regular follow-up.
- 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.
- [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.
Who cannot join
- Gliomas diagnosed or preferred as other categories than ATDGs, such as pediatric-type diffuse gliomas, circumscribed astrocytic gliomas, and others.
- Inability to cooperate by providing a complete medical history.
- Patients disagree to provide archived tumor samples.
- Undesirable compliance.
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Taiwan8 sites, 8 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Ming-Jung Chuang
Ming-Jung Chuang
- Recruiting
Shuang Ho Hospital
New Taipei City
Yong-Kwang Tu
Yong-Kwang Tu
- Recruiting
China Medical University Hospital
Taichung
Chen-Yuan Lin
Chen-Yuan Lin
- Recruiting
Taichung Veterans General Hospital
Taichung
Young-sen Yang
Young-sen Yang
- Recruiting
National Cheng Kung University Hospital
Tainan
Chia-Jui Yen
Chia-Jui Yen
- Recruiting
National Taiwan University Hospital
Taipei
Dar-Ming Lai
Dar-Ming Lai
- Recruiting
Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
Taipei
Yao-Yu Hsieh
Yao-Yu Hsieh
- Recruiting
CHANG GUNG MEMORIAL HOSPITAL, Linkou
Taoyuan
kuo-chen Wei
kuo-chen Wei
About this study
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.
Read the detailed description
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.
- Conditions
- Primary Malignant Brain Tumors
- Keywords
- adult-type diffuse gliomas, next-generation sequencing, precision medicine
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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). | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start29 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Malignant Brain TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwang-Yu Chang, MD,PhD, Study chair, National Health Research Institutes, TaiwanTsang-Wu Liu, MD, Study chair, National Health Research Institutes, TaiwanYong-Kwang Tu, MD, PhD, Principal investigator, Taipei Neuroscience Institute,Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622409
- Sponsor's protocol ID
- T3322
- Status last verified
- Aug 2025
- First submitted
- 13 Nov 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
- ClinicalTrials.gov ID
- NCT05622409
- Acronym / sponsor ID
- T3322
- Conditions
- Primary Malignant Brain Tumors
- Keywords
- adult-type diffuse gliomas, next-generation sequencing, precision medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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). |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (8 listed)
- Pathological confirmation or suggestion of adult-type diffuse gliomas A. Diagnosis includes glioblastoma, astrocytoma, oligodendrocytoma that is listed in ATDG category per WHO criteria.
- Willingness to provide archival or newly obtained tumor tissues for current study proposal.
- Age equal or more than 20 years old (inform consent).
- Life expectancy more than 3 months.
- Patients fully understand the protocol with the willingness to have regular follow-up.
Key exclusion criteria (5 listed)
- Gliomas diagnosed or preferred as other categories than ATDGs, such as pediatric-type diffuse gliomas, circumscribed astrocytic gliomas, and others.
- Inability to cooperate by providing a complete medical history.
- Patients disagree to provide archived tumor samples.
- Undesirable compliance.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the genetic profiles in brain tumor patients in Taiwan.
Time frame: 5 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kwang-Yu Chang, MD,PhD study chair
National Health Research Institutes, Taiwan
Tsang-Wu Liu, MD study chair
National Health Research Institutes, Taiwan
Yong-Kwang Tu, MD, PhD principal investigator
Taipei Neuroscience Institute,Taipei Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Malignant Brain Tumors, run by National Health Research Institutes, Taiwan at 8 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien-Ya Hung (+886-3-7206166 ext. 35104, 951106@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the genetic profiles in brain tumor patients in Taiwan. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.