NCT05622409 A Taiwanese Oncogenetic Panel and Integrated Clinical Data Registry Study for Diffuse Glioma
| NCT ID | NCT05622409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Health Research Institutes, Taiwan |
| Condition | Primary Malignant Brain Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-12-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Kwang-Yu Chang, MD,PhD
STUDY CHAIR
National Health Research Institutes, Taiwan
Frequently Asked Questions
Who can join the NCT05622409 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Primary Malignant Brain Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05622409 currently recruiting?
Yes, NCT05622409 is actively recruiting participants. Contact the research team at 951106@nhri.edu.tw for enrollment information.
Where is the NCT05622409 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan, New Taipei City, Taiwan, Taichung, Taiwan, Taichung, Taiwan and 4 additional locations.
Who is sponsoring the NCT05622409 clinical trial?
NCT05622409 is sponsored by National Health Research Institutes, Taiwan. The principal investigator is Kwang-Yu Chang, MD,PhD at National Health Research Institutes, Taiwan. The trial plans to enroll 250 participants.