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<Purpose of the Research>
<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
<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;
<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The consent to participate has been rescinded in the process of data collection after the completion of the treatment.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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | 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 chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and diagnostic elements |
| Untill the year 2027 |
| Laboratory and pathologic assessments |
| Untill the year 2027 |
| Radiological assessments |
| Untill the year 2027 |
| Radiologic response criteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive assessment | • Neurocognitive functions of patients are highly recommended to be assessed before the initiation of treatment (either chemotherapy or radiotherapy) and at 1 years post-treatment, and every 1-2 years thereafter after the completion of all treatment. | Untill the year 2027 |
| Quality of life assessment |
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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
Exclusion Criteria:
① The patient or the guardian of the patient did not consent to participate.
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Looking at the experience of collecting data for joint research in the Asian region, the number of patients data collected by all institutes including from Singapore, Taiwan, Korea and Japan during a 20-year period (1995-2015) were around 450 for germinoma, and 250 for mixed germinoma. Therefore, the projected collection of patient information from 10 institutes of 4 countries during the 5 years from 2022 to 2027 will be at a similar level, with around 400 patients, combined with two diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joo-young Kim, M.D., Ph.D. | Contact | +82 31 920 1724 | jooyoungcasa@ncc.re.kr | |
| songei Yang, MPH | Contact | +82-31-920-0155 | yse1213@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Joo-young Kim, M.D., Ph.D. | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Recruiting | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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| ID | Term |
|---|---|
| D018237 | Germinoma |
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009423 | Nervous System Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Untill the year 2027 |
| Treatment elements |
| Untill the year 2027 |
| Treatment response, acute and late complications, and survival |
| Untill the year 2027 |
• Under the standard treatment, conduct a survey before initial treatment either chemotherapy or radiotherapy, 1 years post-treatment, and every 1-2 years thereafter after the completion of all treatment (Those who underwent chemotherapy before radiotherapy need to undergo first survey before chemotherapy and additionally a second survey before radiotherapy)
|
| Untill the year 2027 |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |