UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028058 |
|---|---|
| Receipt number | R000031326 |
| Scientific Title | Prospective multicenter disease registry using SCRUM-Japan as an external control group for marketing authorization for pharmaceuticals |
| Date of disclosure of the study information | 2017/07/03 |
| Last modified on | 2023/07/10 12:01:53 |
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Basic information
Public title
Prospective multicenter disease registry using SCRUM-Japan as an external control group for marketing authorization for pharmaceuticals
Acronym
SCRUM-Japan Registry
Scientific Title
Prospective multicenter disease registry using SCRUM-Japan as an external control group for marketing authorization for pharmaceuticals
Scientific Title:Acronym
SCRUM-Japan Registry
Region
| Japan |
Condition
Condition
Unresectable solid malignancies
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To make an external control data in evaluating anticipated new drug application/approval for patients with orphan-fractionated gene alterations by collecting clinical data prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Progression Free Survival, Duration of Response, Time to Treatment Failure, Disease Control Rate, and Overall Survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In order to be eligible, subjects must meet all the following inclusion criteria of 1)-4):
1) Has unresectable solid malignancies.
2) Has undergone to a comprehensive genomic profile that Next Generation Sequencing or related research for scrum-japan.
(i) Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (UMIN000010234)
(ii) The Nationwide Cancer Genome Screening Project for Gastrointestinal Cancer in Japan (SCRUM-Japan GI-SCREEN):Efficient Identification of Actionable Cancer Genome Alterations in Advanced Colorectal Cancer (GI-SCREEN 2013-01) (UMIN000016343)
(iii) The Nationwide Cancer Genome Screening Projects for Gastrointestinal Cancer in Japan, Efficient Identification of Actionable Cancer Genome Alterations in Advanced Non-Colorectal Gastrointestinal Cancer (SCRUM-Japan GI Screen 2015-01-Non-CRC) (UMIN000016344)
(iv)HER2 screening study for metastatic colorectal cancer (additional studies of GI-SCREEN 2013-01-CRC)
(v)A screening study of HER2 expression for biliary tract cancer
(vi)Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer
(vii)Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
(viii)Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies
(ix)A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA
(x)A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors
3) The specific genetic alteration in the gene analysis identified 2), see Other related information.
4) Is at least 20 years of age at the time of registration.
Key exclusion criteria
Subjects have any reason, in the opinion of the investigator, that would preclude participation in this research.
Target sample size
630
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Ohtsu |
Organization
National Cancer Center
Division name
Hospital East
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
aohtsu@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
National Cancer Center
Division name
Hospital East, Department of Gastroenterology and GI Oncology, Translational Research Support Office
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
hbando@east.ncc.go.jp
Sponsor or person
Institute
National Research and Development Agency, National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
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 Board
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 03 | 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
| 2017 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: prospective observational study
Target population: the patients who visit the participating site from the date of study approval to March 31 2024 and meet the eligibility criteria.
Assessments: patient characteristics, treatment regimen and its efficacy, survival outcome etc.
< testing using tumor tissue>
Targeting biomarker: ATM genetic alterations, BARD1 genetic alterations, BRAF NonV600E mutation, BRCA1/2 genetic alterations, BRIP1 genetic alterations, CDK12 genetic alterations, CHEK1/2 genetic alterations, EGFR ex20 insertion, ERBB2 amplification, ERBB2 mutation, FANCL genetic alterations, FGFR1/2/3/4 fusion, FGFR2 amplification, MET amplification, NFE2L2 mutation, NRG1 fusion, PALB2 genetic alterations, RAD51B/C/D genetic alterations, RAD54L genetic alterations,
< testing using blood>
Targeting biomarker: ATM genetic alteration, BARD1 genetic alterations, BRAF NonV600E mutation, BRCA1/2 genetic alterations, BRIP1 genetic alterations, CDK12 genetic alterations, CHEK1/2 genetic alterations, ERBB2 amplification, ERBB2 mutation, FANCL genetic alterations, FGFR1/2/3/4 fusion, FGFR2 amplification, MET amplification, NFE2L2 mutation, PALB2 genetic alterations, RAD51B/C/D genetic alterations, RAD54L genetic alterations
Management information
Registered date
| 2017 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031326
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
