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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• To evaluate the genetic profiles in brain tumor patients in Taiwan. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 8 центров

• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City
• Shuang Ho Hospital — New Taipei City
• China Medical University Hospital — Taichung
• Taichung Veterans General Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Taipei Medical University -Ministry of Health and Welfare Shuang-Ho Hospital — Taipei
• CHANG GUNG MEMORIAL HOSPITAL, Linkou — Taoyuan

Идентификаторы

NCT: NCT05622409 · T3322

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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