Clinical trial NCT05982691: Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
Official title: National Cancer Center Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CNS Germinoma
CNS Tumor
Asian Consortium
Keywords: CNS germinoma
CNS Tumor
Asian Consortium
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2023-08-08
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

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.

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.

Primary outcomes:
measure: Demographic and diagnostic elements
timeFrame: Untill the year 2027
measure: Laboratory and pathologic assessments
timeFrame: Untill the year 2027
measure: Radiological assessments
timeFrame: Untill the year 2027
measure: Radiologic response criteria
timeFrame: Untill the year 2027
measure: Treatment elements
timeFrame: Untill the year 2027
measure: Treatment response, acute and late complications, and survival
timeFrame: Untill the year 2027
Secondary outcomes:
measure: Neurocognitive assessment
timeFrame: Untill the year 2027
measure: Quality of life assessment
timeFrame: Untill the year 2027
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Joo-young Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: