UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008927 |
|---|---|
| Receipt number | R000010467 |
| Scientific Title | Sorting of circulating tumor cells from patients with colon cancer and genomic DNA extraction: a prospective feasibility study |
| Date of disclosure of the study information | 2012/09/15 |
| Last modified on | 2019/09/26 18:40:16 |
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Basic information
Public title
Sorting of circulating tumor cells from patients with colon cancer and genomic DNA extraction: a prospective feasibility study
Acronym
DNA extraction from circulating tumor cells in colon cancer patients: a prospective feasibility study
Scientific Title
Sorting of circulating tumor cells from patients with colon cancer and genomic DNA extraction: a prospective feasibility study
Scientific Title:Acronym
DNA extraction from circulating tumor cells in colon cancer patients: a prospective feasibility study
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We will sort circulating tumor cells from colon cancer patients and extract nucleotide. And, we will compare genomic analysis among circulating tumor cells, primary tumor and normal tissue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Similarity of genomic mutation
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) histologically proven colon cancer
(2) age 20-80 years
(3) sufficient organ function
(4) written informed consent
Key exclusion criteria
(1) synchronous or metachronous malignancy
(2) pregnant or breastfeeding women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ito |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
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 | Hiroaki |
| Middle name | |
| Last name | Ito |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
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
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, JAPAN
Tel
03-3784-8022
m-rinri@ofc.showa-u.ac.jp
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 | 09 | Month | 15 | 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 | 04 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will sort circulating tumor cells from colon cancer patients and extract nucleotide. And, we will compare genomic analysis among circulating tumor cells, primary tumor and normal tissue.
Management information
Registered date
| 2012 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
