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

NCT05982691 | Recruiting DMC

• 1 other identifier: NCC22-0194
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.
• 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

Conditions

CNS Germinoma; CNS Tumor; Asian Consortium

Keywords

CNS germinoma; CNS Tumor; Asian Consortium

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Neurocognitive assessment

  Untill the year 2027

• Quality of life assessment

  Untill the year 2027

Interventions

Radiation Therapy RADIATION

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Germinoma; Central Nervous System Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Joo-young Kim, M.D., Ph.D.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo-young Kim, M.D., Ph.D.

CONTACT

+82 31 920 1724; jooyoungcasa@ncc.re.kr

songei Yang, MPH

CONTACT

+82-31-920-0155; yse1213@ncc.re.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: August 8, 2023
• Study Start: August 5, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

KR (1)