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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036756
Receipt No. 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 2019/05/15

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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 1 year or older at registration.
2. Patients with a final diagnosis of hematologic malignancy from a histology or bone marrow test.
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 100

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
Email nbryamam@ncc.go.jp

Public contact
Name of contact person
1st name Tamie
Middle name
Last name Sukigara
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
Email tsukigar@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Email 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)

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
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041854

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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