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

Last updated: August 7, 2023
Sponsor: National Cancer Center, Korea
Overall Status: Active - Recruiting

Phase

N/A

Condition

Germ Cell Tumors

Gliomas

Astrocytoma

Treatment

Radiation Therapy

Clinical Study ID

NCT05982691
NCC22-0194
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

    -  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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A patient who was diagnosed with CNS GCT and agreed to participate in the researchbetween 2022-2027.
  • Patients diagnosed between 2016-2022 can be enrolled if the participatinginstitute has IRB approval for recruiting these patients as separate IRB document (Seoul Asan Hospital) or by comprehensive IRB document (Singapore NCC, TaiwanMedical University), or by recruitment on the basis of acquirement of the consentform 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 anoperation or a biopsy ⑤ In the case of CNS germinoma, a biopsy may nothave been performed on a patient. In this case, the patient mayregister as germinoma if he or she meets the following criteria: -Germinoma is strongly suspected radiologically, and a tumor markerfrom serum or cerebrospinal fluid (CSF) has not increased above theinstitute's reference normal value; -Germinoma is suspectedradiologically, and a tumor marker from serum or CSF has elevated abovethe institute's reference normal value (tumor markers may be AFP orhCG)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Radiation Therapy
Phase:
Study Start date:
August 05, 2022
Estimated Completion Date:
December 31, 2032

Study Description 

    -  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&lt; ≤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.

Connect with a study center

  • National Cancer Center, Korea

    Goyang-si, Gyeonggi-do 410-769
    Korea, Republic of

    Active - Recruiting

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