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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007431
Receipt No. R000008756
Scientific Title Detection of Circulating tumor cells and cancer stem cells in the peripheral blood samples from digestive tract cancer
Date of disclosure of the study information 2012/03/02
Last modified on 2015/03/02

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Basic information
Public title Detection of Circulating tumor cells and cancer stem cells in the peripheral blood samples from digestive tract cancer
Acronym Detection of circulating tumor cells and cancer stem cells of digestive tract cancer
Scientific Title Detection of Circulating tumor cells and cancer stem cells in the peripheral blood samples from digestive tract cancer
Scientific Title:Acronym Detection of circulating tumor cells and cancer stem cells of digestive tract cancer
Region
Japan

Condition
Condition Esophageal cancer, gastric cancer, gastric submucosal tumor, gastrointestinal stromal tumor, colon cancer and pancreas cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is detection circulating tumor cells and cancer stem cells in the peripheral blood samples from the patients with esophageal cancer, gastric cancer, gastrointestinal stromal tumor of the stomach, colon cancer and pancreas cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of circulating tumor cells, clinicopathological characters, overall survival and disease-free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of circulating tumor cell in peripheral blood from the patients with esophageal cancer
Interventions/Control_2 Measurement of circulating tumor cell in peripheral blood from the patients with gastric cancer
Interventions/Control_3 Measurement of circulating tumor cell in peripheral blood from the patients with the gastrointestinal stromal tumor of the stomach
Interventions/Control_4 Measurement of circulating tumor cell in peripheral blood from the patients with colon cancer
Interventions/Control_5 Measurement of circulating tumor cell in peripheral blood from the patients with pancreas cancer
Interventions/Control_6 Measurement of circulating tumor cell in peripheral blood from the patients without malignancies
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) histologically proven esophageal, gastric and colon cancer. And clinically diagnosed gastrointestinal stromal tumor of the stomach and pancreas cancer
(2) clinical solitary tumor
(3) no prior treatment
(4) age 20-80 years
(5) Eastern Cooperative Oncology Group performance status 0 or 1
(6) sufficient organ function
(7) written informed consent
Key exclusion criteria (1) synchronous or metachronous malignancy
(2) pregnant or breastfeeding women
(3) active or chronic viral hepatitis
(4) active bacterial or fungal infection
(5) diabetes mellitus which needs insulin therapy
(6) systemic administration of corticosteroids
Target sample size 440

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Nothern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL 045-949-7000
Email h.ito@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL 045-949-7000
Homepage URL
Email h.ito@med.showa-u.ac.jp

Sponsor
Institute Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Digestive Disease Center, Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 03 Month 02 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 Completed
Date of protocol fixation
2012 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 02 Day
Last modified on
2015 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008756

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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