National Cancer Center Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Radiological assessments
研究概览
简要总结
<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
详细描述
<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;
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient who was diagnosed with CNS GCT and agreed to participate in the research between 2022-
- •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)
排除标准
- •① The patient or the guardian of the patient did not consent to participate.
结局指标
主要结局
Radiological assessments
时间窗: Untill the year 2027
* Brain and spinal MRI with gadolinium contrast should be obtained at the time of diagnosis. * For early response evaluation, brain MRI is highly recommended to be obtained at radiation dose of 20 Gy in patients who are not given induction chemotherapy. Otherwise, brain MRI should be obtained after induction chemotherapy and before the initiation of radiotherapy. * For final response evaluation, brain MRI should be obtained within 3 months after the completion of radiotherapy.
Treatment response, acute and late complications, and survival
时间窗: Untill the year 2027
* Treatment response (by radiologic imaging, tumor markers), treatment-related acute and late complications, co-morbid condition, last traced date, whether the patient survived or not * Whether the disease relapsed, the date of relapse, the location of relapse (brain or spine, out or inside of final boost field, out or inside of whole ventricular field) * Development of second malignant neoplasm (SMN)
Demographic and diagnostic elements
时间窗: Untill the year 2027
* Sex, date of birth, birth order, weight at birth, education, disability diagnosis, parents' socio-economic information, cancer family history * Age at diagnosis, date of diagnosis, name of diagnosis, pathological name of the diagnosis, ECOG performance status at the time of diagnosis, location of tumor, stage, tumor marker, biopsy, etc.
Laboratory and pathologic assessments
时间窗: Untill the year 2027
* Laboratory assessments include full blood count, PT, PTT, serum electrolytes, alakaline phosphatase, alanine transferase, aspartate aminotransferase, bilirubin, serum creatinine, GFR, serum lactate, and ammonium. * Both of serum and CSF tumor markers including bHCG and AFP are highly recommended to be obtained at the time of diagnosis. Tumor markers in both serum and CSF should be obtained within 3 months after the completion of radiotherapy for final response evaluation. * Biopsy is strongly recommended as a component of diagnostic assessments, even when germinoma is highly suspected based on radiological images and tumor markers. Biopsy is particularly strongly recommended when ß-HCG is higher than 50 mIU/mL.
Radiologic response criteria
时间窗: Untill the year 2027
* Complete response (CR): complete disappearance of visible disease on imaging. allowing for minimal residual disease/enhancement ≤0.5 cm maximal dimension in suprasellar or ≤1cm in pineal locations. * Partial response (PR): \> 0.5 cm dimension residual in the suprasellar area or \> 1 cm residual in pineal location, but ≥ 65% decrease in the sum of the products of the three perpendicular diameters (volume) of all target lesions. * Stable Disease (SD): Neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for PR (taking as reference the initial baseline measurements), nor sufficient increase in a single target lesion to qualify for PD, and residual disease of \> 1.5 cm maximal diameter. * Progressive Disease (PD): 40% or more increase in the product of perpendicular diameters (volume) of any target lesion, or the appearance of one or more new lesions.
Treatment elements
时间窗: Untill the year 2027
* Whether the operation has been performed and the extent of operation if performed * Chemotherapy: Medication used for treatment, treatment response, the timing of treatment (pre- or post-radiation therapy) * Radiation therapy: Site of treatment, treatment volume (radiotherapy field), radiation dose, treatment response, start date, end date
次要结局
- Neurocognitive assessment(Untill the year 2027)
- Quality of life assessment(Untill the year 2027)
研究者
Joo-Young Kim
Principal Investigator
National Cancer Center, Korea