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

Официальное название

National Cancer Center Korea

Обзор

\<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

Подробное описание

\<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* The consent to participate has been rescinded in the process of data collection after the completion of the treatment.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.

Вмешательства

• Лучевая терапия 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

Первичные конечные точки

• Demographic and diagnostic elements [Срок оценки: Untill the year 2027]
• Laboratory and pathologic assessments [Срок оценки: Untill the year 2027]
• Radiological assessments [Срок оценки: Untill the year 2027]
• Radiologic response criteria [Срок оценки: Untill the year 2027]
• Treatment elements [Срок оценки: Untill the year 2027]
• Treatment response, acute and late complications, and survival [Срок оценки: Untill the year 2027]

Вторичные конечные точки (2)

• Neurocognitive assessment [Срок оценки: Untill the year 2027]
• Quality of life assessment [Срок оценки: Untill the year 2027]

Критерии участия

Критерии включения

• 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)

Критерии исключения

① The patient or the guardian of the patient did not consent to participate.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• National Cancer Center, Korea — Goyang-si

Идентификаторы

NCT: NCT05982691 · NCC22-0194

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗