UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007431 |
|---|---|
| Receipt number | 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 09:07:50 |
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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
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
h.ito@med.showa-u.ac.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008756
