A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Malignant Brain Tumors
• Intervention / Treatment: Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Kwang-Yu Chang; Phone Number: 65112 +886-6-7000123; Email: 960826@nhri.edu.tw
• Study Contact Backup: Name: Chien-Ya Hung; Phone Number: 35104 +886-3-7206166; Email: 951106@nhri.edu.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Ming-Jung Chuang
    • Principal Investigator: Ming-Jung Chuang
  • New Taipei City, Taiwan
    • Recruiting
    • Shuang Ho Hospital
    • Contact: Yong-Kwang Tu
    • Principal Investigator: Yong-Kwang Tu
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Principal Investigator: Chen-Yuan Lin
    • Contact: Chen-Yuan Lin
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Young-sen Yang
    • Principal Investigator: Young-sen Yang
  • Tainan City, Taiwan
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Chia-Jui Yen
    • Principal Investigator: Chia-Jui Yen
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Dar-Ming Lai
    • Principal Investigator: Dar-Ming Lai
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital
    • Contact: Yao-Yu Hsieh
    • Principal Investigator: Yao-Yu Hsieh
  • Taoyuan District, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital, Linkou
    • Contact: kuo-chen Wei
    • Principal Investigator: kuo-chen Wei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma; A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
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).	Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma; A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
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.	Other: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma; A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan
• Investigators: Study Chair: Kwang-Yu Chang, MD,PhD, National Health Research Institutes, Taiwan; Study Chair: Tsang-Wu Liu, MD, National Health Research Institutes, Taiwan; Principal Investigator: Yong-Kwang Tu, MD, PhD, Taipei Neuroscience Institute,Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: next-generation sequencing; adult-type diffuse gliomas; precision medicine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: T3322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No