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

National Cancer Center Korea

<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

Study Overview

• Status: Recruiting
• Conditions: CNS Tumor; CNS Germinoma; Asian Consortium
• Intervention / Treatment: Radiation: Radiation Therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Joo-Young Kim, M.D., Ph.D.; Phone Number: +82 31 920 1724; Email: jooyoungcasa@ncc.re.kr
• Study Contact Backup: Name: songei Yang, MPH; Phone Number: +82-31-920-0155; Email: yse1213@ncc.re.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • Recruiting
      • National Cancer Center, Korea
      • Contact: Joo-Young Kim, M.D., Ph.D.; Phone Number: +82 31 920 1724; Email: jooyoungcasa@ncc.re.kr
      • Principal Investigator: Joo-Young Kim, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and diagnostic elements	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.	Untill the year 2027
Laboratory and pathologic assessments	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.	Untill the year 2027
Radiological assessments	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.	Untill the year 2027
Radiologic response criteria	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.	Untill the year 2027
Treatment elements	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	Untill the year 2027
Treatment response, acute and late complications, and survival	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)	Untill the year 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive assessment	• Neurocognitive functions of patients are highly recommended to be assessed before the initiation of treatment (either chemotherapy or radiotherapy) and at 1 years post-treatment, and every 1-2 years thereafter after the completion of all treatment.	Untill the year 2027
Quality of life assessment	• Under the standard treatment, conduct a survey before initial treatment either chemotherapy or radiotherapy, 1 years post-treatment, and every 1-2 years thereafter after the completion of all treatment (Those who underwent chemotherapy before radiotherapy need to undergo first survey before chemotherapy and additionally a second survey before radiotherapy); Pediatric brain tumor (7-12 yrs old, 13-18 yrs old): PED FACT-BRS, Child, Adolescent / Parent; Pediatric Quality of Life 4.0 Generic Core Scale(7-12 yrs old, 13-18 yrs old) : PedsQL, Child, Adolescent / Parent; Quality of Life-Cancer survivors quesionnaire( ≥19 yrs old): QOL-CS-K, adult; Children's depression inventory (7-18 yrs old) : CDI; Self-Esteem Inventory (7-18 yrs old) : SEI	Untill the year 2027

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Joo-young Kim, M.D., Ph.D., National Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: CNS Tumor; CNS germinoma; Asian Consortium
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Germinoma
• Other Study ID Numbers: NCC22-0194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No