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NCT Number: NCT05622409

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Ya Hung

CONTACT

[email protected]

+886-3-7206166 ext. 35104

Kwang-Yu Chang

CONTACT

[email protected]

+886-6-7000123 ext. 65112

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2030
First posted
Nov 18, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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