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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016344
Receipt No. R000018971
Official scientific title of the study 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)
Date of disclosure of the study information 2015/01/26
Last modified on 2017/05/18

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Basic information
Official scientific title of the study 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)
Title of the study (Brief title) SCRUM-Japan GI Screen 2015-01- Non-CRC
Region
Japan

Condition
Condition Gastrointestinal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the frequency or characteristics of cancer genome alterations in advanced non-colorectal gastrointestinal cancers
Basic objectives2 Others
Basic objectives -Others To evaluate the frequency or characteristics of cancer genome alterations in advanced non-colorectal gastrointestinal cancers,Quality of the specimen contributing to gene analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency or characteristics of cancer genome alteration
Key secondary outcomes Association between each cancer genome alterations and clinicopathological characteristics or prognosis,Quality of the specimen contributing to gene analysis

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with histologically confirmed or clinically suspected advanced cancer of following descriptions; 1.gastric or gastro-esophageal junction adenocarcinoma 2.Esophageal cancer(adenocarcinoma or squamous cell carcinoma) 3.Others (adenocarcinoma of small intestine, appendiceal adenocarcinoma, anal cancer, neuroendocrine carcinoma which includes mixed type with adenocarcinoma)

2) Planned to receive systemic chemotherapy for advanced disease
3) Presence or ability to acquire sufficient DNA for target sequencing
4) Written informed consent was obtained
Key exclusion criteria 1) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size 1500

Research contact person
Name of lead principal investigator Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 81-47-133-111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person Kohei Shitara
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email kshitara@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization SCRUM Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2015 Year 01 Month 26 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 01 Month 26 Day
Anticipated trial start date
2015 Year 04 Month 16 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Each cancer genome alterations and clinicopathological characteristics or prognosis,Quality of the specimen contributing to gene analysis

Management information
Registered date
2015 Year 01 Month 26 Day
Last modified on
2017 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018971

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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