UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037563 |
|---|---|
| Receipt number | R000042826 |
| Scientific Title | Utility of liquid biospy using lavage fluid in diagnosis of colorectal cancer |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/01/29 17:58:57 |
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Basic information
Public title
Utility of liquid biospy using lavage fluid in diagnosis of colorectal cancer
Acronym
Liquid biospy of lavage fluid in colorectal cancer
Scientific Title
Utility of liquid biospy using lavage fluid in diagnosis of colorectal cancer
Scientific Title:Acronym
Liquid biospy of lavage fluid in colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate diagnostic ability of lavage fluid taken from the lumen with colorectal cancers by assessing cell-free DNA/cancer cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic ability of liquid biopsy with lavage fluid in colorectal cancer
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20-year-old or more Patients with colorectal neoplasms (including cancers) which is diagnosed endoscopy
Key exclusion criteria
Patients who is considered unsuitable for the enrollment of this study (e.g., ones with unstable condition)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 1138603, Japan
TEL
0338222131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 1138603, Japan
TEL
0338222131
Homepage URL
o-goto@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Graduate School of Medicine
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
Center for Clinical Research, Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 1138603, Japan
Tel
0338222131
inq-ccr@nms.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
| 2019 | Year | 08 | Month | 01 | 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
4
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
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In patients with colorectal neoplasms (including cancers) which is diagnosed endoscopically, lavage fluid is collected during endoscopy and cell-free DNA/circulating tumor cells are assessed to investigate the potential of less-invasive diagnostic ability in colorectal cancers.
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042826
| Research Plan | |
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| 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 |
