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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Health Research Institutes, Taiwan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Pathological confirmation or suggestion of adult-type diffuse gliomas A. Diagnosis includes glioblastoma, astrocytoma, oligodendrocytoma that is listed in ATDG category per WHO criteria.

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.

Disqualifiers

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.

Trial population

Arm 1: (Newly diagnosis arm): Anticipated 100 patients. Arm 2: IDH expression (N=83 for IDH-mutant and N=82 for IDH-wild type) Arm 3:Recurrent and paired samples (N=10).

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 3 trial groups
Group A: Arm 1
Group B: Arm 2
Group C: Arm 3

Trial outcomes

Primary outcomes

1

To evaluate the genetic profiles in brain tumor patients in Taiwan.

ACTonco+ACTFusion Biospecimen Retention: Samples With DNA One H\&E staining slide, and 15-20 tissue slides (5 um thickness) for cancer panel. Details of Tests/Collaborative Test Unit: Testing will take place in a certified precision medicine laboratory. Non-tumor Sample (Blood): Seven(7)ml of cell free DNA and Eight (8) ml of blood in EDTA tube will be collected from the participant

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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