Trial Title:
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
NCT ID:
NCT05622409
Condition:
Primary Malignant Brain Tumors
Conditions: Official terms:
Glioma
Brain Neoplasms
Conditions: Keywords:
adult-type diffuse gliomas
next-generation sequencing
precision medicine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
Description:
A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse
Glioma
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 3
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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Ming-Jung Chuang
Investigator:
Last name:
Ming-Jung Chuang
Email:
Principal Investigator
Facility:
Name:
Shuang Ho Hospital
Address:
City:
New Taipei City
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yong-Kwang Tu
Investigator:
Last name:
Yong-Kwang Tu
Email:
Principal Investigator
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun-Chung Chen
Investigator:
Last name:
Chun-Chung Chen
Email:
Principal Investigator
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chiung-Chyi Shen
Investigator:
Last name:
Chiung-Chyi Shen
Email:
Principal Investigator
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
E-Jian Lee
Investigator:
Last name:
E-Jian Lee
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Dar-Ming Lai
Investigator:
Last name:
Dar-Ming Lai
Email:
Principal Investigator
Facility:
Name:
Taipei Medical University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yung-Hsiao Chiang
Investigator:
Last name:
Yung-Hsiao Chiang
Email:
Principal Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Sanford PC Hsu
Investigator:
Last name:
Sanford PC Hsu
Email:
Principal Investigator
Facility:
Name:
CHENG GUNG MEMORIAL HOSPITAL, Linkou
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
kuo-chen wei
Investigator:
Last name:
kuo-chen wei
Email:
Principal Investigator
Start date:
December 29, 2022
Completion date:
December 31, 2030
Lead sponsor:
Agency:
National Health Research Institutes, Taiwan
Agency class:
Other
Source:
National Health Research Institutes, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622409
