Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiation Therapy.
- Who it may be relevant to
- Registry conditions: CNS Germinoma, CNS Tumor, Asian Consortium. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
National Cancer Center Korea
Overview
\<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
Detailed description
\<Selection standards\>
* 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 ⑤In 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\> ①The patient or the guardian of the patient did not consent to participate.
\<Attrition criteria\>
* The patient refuses the treatment plan when the treatment is not completed.
* The consent to participate has been rescinded in the process of data collection after the completion of the treatment.
③The research subject expresses the intention to rescind the consent to participate after the subject reaches the age of majority.
\<Recruitment through an international multi-agency network\> Managers at Korean institutions who agreed to participate in the research are charged with the registration of patient information. Internationally, researchers in each institution in Singapore, Taiwan, Thailand, and Korea which agreed to participate in the research enter the information by logging into a registration system.
Each institution obtained approval from its respective institutional review board.
Interventions
- Radiation Radiation Therapy
Radiation Therapy(General guideline) Patients will receive radiotherapy after induction chemotherapy or right after diagnosis without diagnosis. The dose and fields of radiation will be according to the histology, presence of dissemination, and response to the induction chemotherapy or radiotherapy. Radiation therapy can be administered using either of photons or protons. When induction chemotherapy is administered, radiotherapy is recommended to be started within 6 weeks from the last chemother
Primary outcome measures
- Demographic and diagnostic elements [Time frame: Untill the year 2027]
- Laboratory and pathologic assessments [Time frame: Untill the year 2027]
- Radiological assessments [Time frame: Untill the year 2027]
- Radiologic response criteria [Time frame: Untill the year 2027]
- Treatment elements [Time frame: Untill the year 2027]
- Treatment response, acute and late complications, and survival [Time frame: Untill the year 2027]
Secondary outcome measures (2)
- Neurocognitive assessment [Time frame: Untill the year 2027]
- Quality of life assessment [Time frame: Untill the year 2027]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- National Cancer Center, Korea — Goyang-si
Identifiers
NCT: NCT05982691 · NCC22-0194