Unique ID issued by UMIN | UMIN000027552 |
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Receipt number | R000031568 |
Scientific Title | A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare cancers; MASTER KEY Protocol |
Date of disclosure of the study information | 2017/05/31 |
Last modified on | 2023/06/05 13:13:00 |
A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare cancers; MASTER KEY Protocol
Marker Assisted Selective ThErapy in Rare cancers: Knowledge database Establishing registrY Protocol; MASTER KEY Protocol
A prospective clinical registry study of genetic profiling and targeted therapies in patients with rare cancers; MASTER KEY Protocol
Marker Assisted Selective ThErapy in Rare cancers: Knowledge database Establishing registrY Protocol; MASTER KEY Protocol
Japan |
Rare cancer, cancer of unknown primary, and rare histological subtypes of common cancers
Hematology and clinical oncology | Pediatrics |
Malignancy
YES
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 cancers.
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).
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
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients aged 0 years or older at registration.
2. Patients with histological diagnosis of rare cancer, cancer of unknown primary, or rare histological subtypes of common cancers.
3. Patients with incurable progressive (metastatic and/or unresectable) lesions (number of prior regimens will not be limited).
4. Patients who had already received next-generation sequencing (NGS) or molecular diagnostic testing (e.g., immunohistochemical staining, FISH), patients with these tests requested, or patients who have provided oral or written consent for these tests (whether conducted by 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, those who are physically unable to give a signature can have it done by someone appointed by the patient.
1. Patients with complications of psychiatric disorders/symptoms that interfere daily life are considered to hamper their participation in the study.
1000
1st name | Noboru |
Middle name | |
Last name | Yamamoto |
National Cancer Center Hospital
Department of Experimental Therapeutics
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3542-2511
nbryamam@ncc.go.jp
1st name | Masahiko |
Middle name | |
Last name | Ichimura |
National Cancer Center Hospital
Clinical Trial Management Section, Research Management Division, Clinical Research Support Office
104-0045
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3542-2511
https://www.ncc.go.jp/jp/masterkeyproject/index.html
NCCH1612_office@ml.res.ncc.go.jp
National Cancer Center
Astellas, Eisai, Ono., Kyorin, Daiichi Sankyo, Taiho, Takeda, Chugai, Novartis, Pfizer, BMS, Otsuka, Bayer, Boehringer, SymBio, Merck, Servier
Profit organization
National Cancer Center Institutional Review Board
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
NO
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)、京都大学医学部附属病院(京都府)、九州大学病院(福岡県)、北海道大学病院(北海道)、東北大学病院(宮城県)、国立成育医療研究センター(東京都)
2017 | Year | 05 | Month | 31 | Day |
Partially published
Open public recruiting
2017 | Year | 05 | Month | 09 | Day |
2017 | Year | 05 | Month | 10 | Day |
2017 | Year | 05 | Month | 10 | Day |
2030 | Year | 05 | Month | 09 | Day |
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
2017 | Year | 05 | Month | 30 | Day |
2023 | Year | 06 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031568
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