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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 2017/07/03

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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 Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, Non-Squamous non-small cell lung cancer, Squamous non-small cell lung cancer
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 in patients enrolled into the nation-wide genome screening consortium in Japan (SCRUM-Japan)
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)-3):

1) Have been registered in one of the following clinical research (SCRUM-Japan study) which is being conducted at 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)

2) Have tumor that meets the following either (a) or (b).
(a) The specific genetic alteration specified in "Other related information" in the gene analysis carried out in any of 1) (i), (ii), or (iii).
(b) Positive for the test carried out in any of following research: "Studies on HER2 screening for patients with unresectable or recurrent colorectal cancer (tentative name)", "Research on BRAF screening for patients with unresectable or recurrent colorectal cancer (tentative name)", "Researches on patients with unresectable or recurrent biliary tract cancer Study on HER2 screening (tentative name) ".

3) Have given written informed consent for this research.
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
Middle name
Last name Atsushi Ohtsu
Organization National Cancer Center
Division name Hospital East
Zip code
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
Middle name
Last name Wataru Okamoto
Organization National Cancer Center
Division name Hospital East, Clinical Research Support Office, TR Management Division, BB/TR Support Section
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email wokamoto@east.ncc.go.jp

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

Funding Source
Organization National Research and Development Agency, Japan Agency for Medical Research and Development.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
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 2019 and meet the eligibility criteria
Assessments: patient characteristics, treatment regimen and its efficacy, survival outcome etc.
Targeting biomarker: [Colorectal cancer] BRAF mutation, ERBB2 amplification, MET amplification, NTRK fusion, RSPO2/3 fusion, RNF43 mutation, HER2 positive (IHC, ISH etc.), BRAF positive (PCR etc.). [Gastric cancer] FGFR2 amplification, MET amplification. [Esophageal cancer] ERBB2 amplification, PIK3CA mutation or amplification. [non-Squamous non-small cell lung cancer] RET fusion, MET ex14skiping or amplification, ERBB2 mutation or amplification. [Squamous cell lung cancer] FGFR1/2/3 amplification or fusion, PIK3CA mutation or amplification. [Biliary tract cancer] FGFR2 fusion, ERBB2 amplification, IDH1 mutation, HER2 positive (IHC, ISH etc.). [Pancreatic cancer] BRCA2 mutation, ATM mutation, PALB2 mutation.

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