CNS GerminomaNCT05982691
Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors
An observational study of CNS Germinoma and CNS Tumor, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CNS Germinoma, CNS Tumor, Asian Consortium
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Aug 2022to 31 Dec 2032
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- ① The patient or the guardian of the patient did not consent to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 410-769
Joo-Young Kim, M.D., Ph.D., +82 31 920 1724, jooyoungcasa@ncc.re.kr
Joo-Young Kim, M.D., Ph.D.
About this study
Official title: 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
Read the 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
- Being tested
- Radiation Therapy
- Keywords
- CNS germinoma, CNS Tumor, Asian Consortium
- Medical subject headings
- Germinoma, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Untill the year 2027
Secondary outcomes (2)
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.
Measured: 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
Measured: Untill the year 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start5 Aug 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS GerminomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joo-Young Kim, National Cancer Center, Korea
- Investigators
- Joo-young Kim, M.D., Ph.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982691
- Sponsor's protocol ID
- NCC22-0194
- Status last verified
- Aug 2023
- First submitted
- 30 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cancer Center Korea
- ClinicalTrials.gov ID
- NCT05982691
- Acronym / sponsor ID
- NCC22-0194
- Conditions
- CNS Germinoma, CNS Tumor, Asian Consortium
- Keywords
- CNS germinoma, CNS Tumor, Asian Consortium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
<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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- A patient who was diagnosed with CNS GCT and agreed to participate in the research between 2022-2027.
Key exclusion criteria (1 listed)
- ① The patient or the guardian of the patient did not consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyRadiation 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. | Radiation | – |
Primary outcome
Demographic and diagnostic elements
Time frame: 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
Time frame: 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.
Radiological assessments
Time frame: 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.
Radiologic response criteria
Time frame: 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
Time frame: 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
Treatment response, acute and late complications, and survival
Time frame: 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)
2 secondary outcomes
Neurocognitive assessment
Time frame: Untill the year 2027
Quality of life assessment
Time frame: Untill the year 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joo-young Kim, M.D., Ph.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Germinoma and CNS Tumor, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo-young Kim, M.D., Ph.D. (+82 31 920 1724, jooyoungcasa@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and diagnostic elements (time frame: Untill the year 2027). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.