UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029549 |
|---|---|
| Receipt number | R000033675 |
| Scientific Title | Predictive model for lymph node metastasis of colorectal cancer - using PET / CT |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/04/17 15:59:15 |
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Basic information
Public title
Predictive model for lymph node metastasis of colorectal cancer - using PET / CT
Acronym
Predictive model for lymph node metastasis of colorectal cancer
Scientific Title
Predictive model for lymph node metastasis of colorectal cancer - using PET / CT
Scientific Title:Acronym
Predictive model for lymph node metastasis of colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the predictive model for lymph node metastasis of colorectal cancer using PET / CT
Basic objectives2
Others
Basic objectives -Others
It is important to diagnose precisely lateral lymph node metastasis of advanced lower rectal cancers for treatment. We aim to establish the predictive model for lymph node metastasis of colorectal cancer using PET / CT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of the predictive model for lymph node metastasis of 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as colorectal cancer pathologically (adenocarcinoma, pap / tub / por) and planned to undergo curative surgery
2. Patients diagnosed as advanced cancer by colonoscopy or barium enema
3. Patients planned to undergo enhanced CT and PET / CT
Key exclusion criteria
1. Patients who underwent neoadjuvant therapy (chemotherapy or radiotherapy)
2. Patients who underwent colon surgery, except appendectomy
3. Patients who have poor-controlled diabetes mellitus (Blood sugar was over 200 mg/dL when PET / CT was performed)
4. Patients who have renal dysfunction
5. Patients who have allergy to contrast agent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Todate |
Organization
Southern Tohoku General Hospital
Division name
Department of Surgery
Zip code
963-8563
Address
7-115, Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5322
totty.todate@gmail.com
Public contact
Name of contact person
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Todate |
Organization
Southern Tohoku General Hospital
Division name
Department of Surgery
Zip code
963-8563
Address
7-115, Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5322
Homepage URL
totty.todate@gmail.com
Sponsor or person
Institute
Southern Tohoku General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Southern Tohoku General Hospital
Address
7-115, Yatsuyamada, Koriyama, Fukushima
Tel
024-934-5322
totty.todate@gmail.com
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
| 2017 | Year | 11 | 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
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033675
