UMIN-CTR Clinical Trial

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
Last 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
Email	totty.todate@gmail.com

Public contact
1st 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
Email	totty.todate@gmail.com

Sponsor
Institute	Southern Tohoku General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033675