Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors

NCT ID: NCT05982691

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2032-12-31

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.

Conditions

CNS Germinoma; CNS Tumor; Asian Consortium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

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 chemotherapy.

Intervention Type: RADIATION

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joo-Young Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joo-young Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Joo-young Kim, M.D., Ph.D.

Role: CONTACT

jooyoungcasa@ncc.re.kr

+82 31 920 1724

songei Yang, MPH

Role: CONTACT

yse1213@ncc.re.kr

+82-31-920-0155

Facility Contacts

Joo-Young Kim, M.D., Ph.D.

Role: primary

jooyoungcasa@ncc.re.kr

+82 31 920 1724

Other Identifiers

NCC22-0194

Identifier Type: -

Identifier Source: org_study_id