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

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

NCT ID: NCT05982691

Condition: CNS Germinoma
CNS Tumor
Asian Consortium

Conditions: Official terms:
Central Nervous System Neoplasms
Germinoma

Conditions: Keywords:
CNS germinoma
CNS Tumor
Asian Consortium

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Radiation
Intervention name: Radiation Therapy
Description: 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.

Summary: - 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 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: - 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) ①The patient or the guardian of the patient did not consent to participate. - 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. 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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Probability Sample
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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: National Cancer Center, Korea

Address:
City: Goyang-si
Zip: 410-769
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Joo-Young Kim, M.D., Ph.D.

Phone: +82 31 920 1724
Email: jooyoungcasa@ncc.re.kr

Investigator:
Last name: Joo-Young Kim, M.D., Ph.D.
Email: Principal Investigator

Start date: August 5, 2022

Completion date: December 31, 2032

Lead sponsor:
Agency: National Cancer Center, Korea
Agency class: Other

Source: National Cancer Center, Korea

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05982691