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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033702
Receipt No. R000038428
Official scientific title of the study Diagnostic accuracy of MRI in lateral pelvic lymph node metastasis of rectal cancer
Date of disclosure of the study information 2018/08/09
Last modified on 2018/08/09

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Basic information
Official scientific title of the study Diagnostic accuracy of MRI in lateral pelvic lymph node metastasis of rectal cancer
Title of the study (Brief title) Diagnostic accuracy of MRI in lateral pelvic lymph node metastasis of rectal cancer
Region
Japan Europe

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the diagnostic criteria of lateral pelvic lymph node (LLN) metastasis on MRI
Basic objectives2 Others
Basic objectives -Others To establish the diagnostic criteria of lateral pelvic lymph node (LLN) metastasis on MRI
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The diagnostic sensitivity of LLN metastasis on MRI
Key secondary outcomes 1. The specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of the diagnosis of LLN metastasis on MRI.
2. The coincidence ratio of morphologic change assessments among the observers
3. The correlation between extramural venous invasion (EMVI) of the primary lesion and LLN metastasis
4. The influence of neoadjuvant therapy for the diagnosis of LLN metastasis on MRI
5. The correlation between the LLN metastasis diagnosed by MRI and the patients' prognosis
6. The difference between the diagnostic accuracy of LLN metastasis on MRI and CT

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
1 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria 1) A case with primary rectal cancer is scheduled for TME and LLND
2) A case with histologically confirmed adenocarcinoma
3) Informed consent is obtained for participation in the study
4) Regarding Step 1, the postoperative registration is permissible.
Key exclusion criteria aa
Target sample size 272

Research contact person
Name of lead principal investigator Kazushie Kawai
Organization The University of Tokyo
Division name Department of Surgical Oncology
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
TEL +81-3-3815-5411
Email kz-kawai@mvd.biglobe.ne.jp

Public contact
Name of contact person Kazushie Kawai
Organization The University of Tokyo
Division name Department of Surgical Oncology
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL +81-3-3815-5411
Homepage URL
Email kz-kawai@mvd.biglobe.ne.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Japanese Society of Cancer of the Colon and Rectum
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 08 Month 09 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 12 Day
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Not applicable

Management information
Registered date
2018 Year 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038428

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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