UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036756 |
|---|---|
| Receipt number | R000041854 |
| Scientific Title | A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare hematologic malignancies; MASTER KEY HEM Protocol |
| Date of disclosure of the study information | 2019/05/16 |
| Last modified on | 2023/11/21 12:20:55 |
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Basic information
Public title
A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare hematologic malignancies; MASTER KEY HEM Protocol
Acronym
Marker Assisted Selective ThErapy in Rare cancers: Knowledge database Establishing registrY Protocol for hematologic malignancy; MASTER KEY HEM Protocol
Scientific Title
A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare hematologic malignancies; MASTER KEY HEM Protocol
Scientific Title:Acronym
Marker Assisted Selective ThErapy in Rare cancers: Knowledge database Establishing registrY Protocol for hematologic malignancy; MASTER KEY HEM Protocol
Region
| Japan |
Condition
Condition
Rare hematologic malignancies
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze the cancer type-specific incidence of genetic abnormalities, relationship between cancer types and prognosis, and effect of individual treatments, etc. in patients with rare hematologic malignancies.
Basic objectives2
Others
Basic objectives -Others
To comprehensively enroll patients into an intervention study (sub-study) depending on the results of biomarkers and availability of appropriate drugs (a separate informed consent is mandatory).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Overall incidence of genetic abnormality
2) Incidence of individual genetic abnormalities
3) Biomarker-positive rate
4) Number of somatic mutations and distribution of mutation rate within exons
5) Response rate
6) Disease control rate
7) Overall survival
8) Progression-free survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 0 year or older at registration.
2. Patients with a final diagnosis of hematologic malignancy from a histology, cytology, flowcytometory, cytogenetic analysis or molecular genetic analysis.
3. Patients with hematologic malignancies with no radical standard therapy (whether new or recurrent).
4. Patients who already have results from an NGS analysis or molecular diagnostic testing (e.g., immunohistochemistry, FISH, RT-PCR) conducted by either own site or an external laboratory or patients with these tests requested from either own site or an external laboratory.
5. Patients who provided a written consent to participate in the study (for patients less than 20 years of age, their legally acceptable representative must give consent). However, if the patient understands the explanation and wishes to consent but has a physical disability in signing due to nerve symptoms, a legal representative may sign on the patient's behalf to confirm consent, if the patient wishes (the patient will appoint one of the following as a legal representative: the patient's spouse, adult child, parent, adult sibling, adult grandchild, grandparent, family member of the same household or considered to be of a status equivalent to that of a close relative).
Key exclusion criteria
1. Patients with complications of psychiatric disorders/symptoms that interfere daily life are considered to hamper their participation in the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-3542-2511
nbryamam@ncc.go.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Ichimura |
Organization
National Cancer Center Hospital
Division name
Clinical Trial Support Office
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-3542-2511
Homepage URL
https://www.ncc.go.jp/jp/masterkeyproject/index.html
michimur@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Astellas, Eisai, Ono., Kyorin, Daiichi Sankyo, Taiho, Takeda, Chugai, Novartis, Pfizer Japan, Bristol-Myers Squibb, Ignyta, Otsuka, Bayer Yakuhin
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Borad
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人 国立がん研究センター中央病院（東京都）、京都大学医学部付属病院（京都府）、東北大学病院（宮城県）、九州大学病院（福岡県）、国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This registry study will evaluate the following endpoints: Overall incidence of genetic abnormality, incidence of individual genetic abnormalities, biomarker-positive rate, and number of somatic mutations and distribution of mutation rate within exons,response rate, disease control rate, overall survival, and progression-free survival
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041854
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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