NCT05982691 Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
| NCT ID | NCT05982691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Center, Korea |
| Condition | CNS Germinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-08-05 |
| Primary Completion | 2028-12-31 |
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 400 participants in total. It began in 2022-08-05 with a primary completion date of 2028-12-31.
⚠ 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
\<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
Eligibility Criteria
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.
Contact & Investigator
Joo-young Kim, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
National Cancer Center
Frequently Asked Questions
Who can join the NCT05982691 clinical trial?
This trial is open to participants of all sexes, studying CNS Germinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05982691 currently recruiting?
Yes, NCT05982691 is actively recruiting participants. Contact the research team at jooyoungcasa@ncc.re.kr for enrollment information.
Where is the NCT05982691 trial being conducted?
This trial is being conducted at Goyang-si, South Korea.
Who is sponsoring the NCT05982691 clinical trial?
NCT05982691 is sponsored by National Cancer Center, Korea. The principal investigator is Joo-young Kim, M.D., Ph.D. at National Cancer Center. The trial plans to enroll 400 participants.