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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028058
Receipt No. 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 2020/07/03

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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

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
Email aohtsu@east.ncc.go.jp

Public contact
Name of contact person
1st name Hiroya
Middle name
Last name Taniguchi
Organization National Cancer Center
Division name Hospital East, Department of Gastroenterology and GI Oncology, Clinical Research Support Office
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email hirtanig@east.ncc.go.jp

Sponsor
Institute National Research and Development Agency, National Cancer Center
Institute
Department

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
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

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
2024 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 2022 and meet the eligibility criteria.
Assessments: patient characteristics, treatment regimen and its efficacy, survival outcome etc.
<Gene testing using tumor tissue>
Targeting biomarker: BRAF NonV600E mutation, MET amplification, RSPO2 fusion, RSPO3 fusion, RNF43 mutation, ERBB2 amplification, FGFR1 mutation, FGFR2 mutation, FGFR3 mutation, FGFR4 mutation, FGFR1 amplification, FGFR2 amplification, FGFR3 amplification, FGFR4 amplification, FGFR1 fusion, FGFR2 fusion, FGFR3 fusion,
FGFR4 fusion, HER2 positive (IHC, ISH etc.), KRAS G12C mutation, AKT1 mutation, ERBB2 mutation, ROS1 fusion. BRCA1 mutation, BRCA2 mutation, CHEK1 mutation, CHEK2 mutation, CDK12 mutation, ATM mutation, ATR mutation, PALB2 mutation, PPP2R2A mutation, IDH1 mutation, MET ex14skiping, EGFR ex20 ins., PIK3CA mutation and PIK3CA amplification.
<Gene testing using circulating tumor DNA in blood>
Targeting biomarker: BRAF NonV600E mutation, MET amplification, ERBB2 amplification, FGFR1/2/3 mutation, FGFR1/2 amplification and FGFR2/3 fusion.

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2020 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031326

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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