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

Last updated: May 8, 2023
Sponsor: National Health Research Institutes, Taiwan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Astrocytoma

Brain Cancer

Brain Tumor

Treatment

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

Clinical Study ID

NCT05622409
T3322
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathological confirmation or suggestion of adult-type diffuse gliomas A. Diagnosisincludes glioblastoma, astrocytoma, oligodendrocytoma that is listed in ATDG categoryper WHO criteria. B. Gliomas that are preferred as ATDGs from pathological and clinical views, but notgiven for confirmed diagnosis.
  2. Willingness to provide archival or newly obtained tumor tissues for current studyproposal.
  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 forprimary tumor. B. [Arm 2] Total resection of primary tumors with tissue samplesavailable for test. C. [Arm 3] (1) Total resection of primary tumors with the paired primary and recurrenttissue samples available for test. (2) IDH test suggesting wild-type.

Exclusion

Exclusion Criteria:

  1. Gliomas diagnosed or preferred as other categories than ATDGs, such as pediatric-typediffuse 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 activetreatment 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 insitu) that have undergone potentially curative therapy are not excluded.

Study Design

Total Participants: 275
Treatment Group(s): 1
Primary Treatment: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
Phase:
Study Start date:
December 29, 2022
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Shuang Ho Hospital

    New Taipei City,
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung,
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung,
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • CHENG GUNG MEMORIAL HOSPITAL, Linkou

    Taoyuan,
    Taiwan

    Site Not Available

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