Clinical trial NCT05622409: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
Official title: A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Malignant Brain Tumors
Keywords: adult-type diffuse gliomas
next-generation sequencing
precision medicine
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 275
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arm 1: (Newly diagnosis arm): Anticipated 150 patients. Arm 2: IDH expression (N=50 for IDH-mutant and N=50 for IDH-wild type) Arm 3:Recurrent and paired samples (N=25).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the genetic profiles in advanced thyroid cancer patients in Taiwan.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: CHENG GUNG MEMORIAL HOSPITAL, Linkou
Study officials:
References: