UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039815 |
|---|---|
| Receipt number | R000045404 |
| Scientific Title | Prediction of lymph node metastasis in early colorectal cancer by liquid biopsy |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/03/15 09:06:21 |
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Basic information
Public title
Evaluation on a possible risk of lymph node metastasis in early colorectal cancers by using circulating tumor DNA
Acronym
Prediction of lymph node metastasis in early colorectal cancer by liquid biopsy
Scientific Title
Prediction of lymph node metastasis in early colorectal cancer by liquid biopsy
Scientific Title:Acronym
Prediction of lymph node metastasis in early colorectal cancer by liquid biopsy
Region
| Japan |
Condition
Condition
Early colorectal cancers
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a prediction method of lymph node metastasis and prognosis in possible node-positive early colorectal cancers for endoscopic or surgical resection by using liquid biopsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of lymph node metastasis and prognosis in cases with positive circulating tumor DNA before or after resection
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
Clinically-diagnosed sumucsoal colorectal cancers
Key exclusion criteria
Cases with severe comorbidities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School Hospital
Division name
Gastroenterology and Hepatology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81338222131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School Hospital
Division name
Gastroenterology and Hepatology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
0338222131
Homepage URL
o-goto@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Nippon Medical School
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 Hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 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
| 2020 | Year | 05 | 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
3
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
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To monitor existence of lymph node metastases and prognosis in cases with positive circulating tumor DNA before or after resection
Management information
Registered date
| 2020 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045404
