UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002018 |
|---|---|
| Receipt number | R000002461 |
| Scientific Title | Prospective study of correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer |
| Date of disclosure of the study information | 2009/05/29 |
| Last modified on | 2016/12/04 09:58:42 |
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Basic information
Public title
Prospective study of correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer
Acronym
Prognosis and quantitative detection of circulating tumor cell (CTC) in blood from patients with gastric cancer
Scientific Title
Prospective study of correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer
Scientific Title:Acronym
Prognosis and quantitative detection of circulating tumor cell (CTC) in blood from patients with gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate correlation between prognosis and quantitative detection of circulating tumor cell (CTC) in blood from patients with gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
measured value of circulating tumor cell (CTC)in peripheral blood, overall survival and relapse-free survival
Key secondary outcomes
Tumor clinical factor, tumor pathological factor and patients background
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gastric cancer patient
Informed consent
Key exclusion criteria
Association of malignant neoplasms of other organs
Target sample size
150
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 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
Homepage URL
h.ito@med.showa-u.ac.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Nothern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Nothern Yokohama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SYSMEX CORPORATION
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
| 2009 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2009 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 29 | Day |
Last modified on
| 2016 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002461
