Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
Recruiting now
Conditions studied: CNS Germinoma, CNS Tumor, Asian Consortium
In brief
\<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
Key facts
- Study ID
- NCT05982691
- Run by
- National Cancer Center, Korea
- People needed
- 400
- Starts
- 2022-08-05
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2023-08-08
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- ① The patient or the guardian of the patient did not consent to participate.
Where it is running
- National Cancer Center, Korea — Goyang-si, Gyeonggi-do, South Korea (enrolling)
Full record on ClinicalTrials.gov
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