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

NCT05622409 | Recruiting DMC

• 1 other identifier: T3322
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Primary Malignant Brain Tumors

Keywords

adult-type diffuse gliomas; next-generation sequencing; precision medicine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (8)

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 District, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. One H\&E staining slide, and 15-20 tissue slides (5 um thickness) for cancer panel. 2. Details of Tests/Collaborative Test Unit: Testing will take place in a certified precision medicine laboratory. 3. Non-tumor Sample (Blood): Fifteen (15) ml of blood will be collected from the participant: 7 ml in EDTA tube (purple top) and 8 ml in Cell-Free DNA blood collection tube.

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kwang-Yu Chang, MD,PhD

  National Health Research Institutes, Taiwan

  STUDY CHAIR

• Tsang-Wu Liu, MD

  National Health Research Institutes, Taiwan

  STUDY CHAIR

• Yong-Kwang Tu, MD, PhD

  Taipei Neuroscience Institute,Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Ya Hung

CONTACT

+886-3-7206166; 951106@nhri.edu.tw

Kwang-Yu Chang

CONTACT

+886-6-7000123; 960826@nhri.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 18, 2022
• Study Start: December 29, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

TW (8)