Clinical trial · Observational
Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
National Cancer Center Korea
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
\<Purpose of the Research\> * Primary Establishing an Asian consortium to establish a database of pediatric CNS tumors in the prospective manner The target disease of this research focuses on pediatric tumors, and initially the registration of patients with CNS GCT will begin first. * Secondary Developing clinical protocols for pediatric CNS tumors based in Asia \<Duration of Research Participation\> Registration period for research subjects: 2022-08-01 - 2027-12-31 Duration of medical records to be utilized: to 2030-12-31 Total projected duration of research: IRB approved to 2032-12-31 Interim assessment of data quality and integrity: 6 Mo after Data collection Evaluation for the Adaptation of Protocols: 1 and 2 years after the initiation of the study Analysis of Quality of Life and other questionnaires: 3 and 5 years Interim Analysis of all data: 5 years (2027) Final analysis of treatment outcome: 2032
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asian Consortium | — | UNRESOLVED | — |
| CNS Germinoma | — | UNRESOLVED | — |
| CNS Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Demographic and diagnostic elements
- timeFrame
- Untill the year 2027
- description
- * Sex, date of birth, birth order, weight at birth, education, disability diagnosis, parents' socio-economic information, cancer family history * Age at diagnosis, date of diagnosis, name of diagnosis, pathological name of the diagnosis, ECOG performance status at the time of diagnosis, location of tumor, stage, tumor marker, biopsy, etc.
- measure
- Laboratory and pathologic assessments
- timeFrame
- Untill the year 2027
- description
- * Laboratory assessments include full blood count, PT, PTT, serum electrolytes, alakaline phosphatase, alanine transferase, aspartate aminotransferase, bilirubin, serum creatinine, GFR, serum lactate, and ammonium. * Both of serum and CSF tumor markers including bHCG and AFP are highly recommended to be obtained at the time of diagnosis. Tumor markers in both serum and CSF should be obtained within 3 months after the completion of radiotherapy for final response evaluation. * Biopsy is strongly recommended as a component of diagnostic assessments, even when germinoma is highly suspected based on radiological images and tumor markers. Biopsy is particularly strongly recommended when ß-HCG is higher than 50 mIU/mL.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria:
* A patient who was diagnosed with CNS GCT and agreed to participate in the research between 2022-2027.
* Patients diagnosed between 2016-2022 can be enrolled if the participating institute has IRB approval for recruiting these patients as separate IRB document (Seoul Asan Hospital) or by comprehensive IRB document (Singapore NCC, Taiwan Medical University), or by recruitment on the basis of acquirement of the consent form for research (NCC, Korea).
* The age at the time of diagnosis is 0\< ≤40 years
* A patent who has been diagnosed with the relevant tumor via an operation or a biopsy ⑤ In the case of CNS germinoma, a biopsy may not have been performed on a patient. In this case, the patient may register as germinoma if he or she meets the following criteria: -Germinoma is strongly suspected radiologically, and a tumor marker from serum or cerebrospinal fluid (CSF) has not increased above the institute's reference normal value; -Germinoma is suspected radiologically, and a tumor marker from serum or CSF has elevated above the institute's reference normal value (tumor markers may be AFP or hCG)
Exclusion Criteria:
① The patient or the guardian of the patient did not consent to participate.References
Publications (0)
Data not yet available