UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033702 |
|---|---|
| Receipt number | R000038428 |
| Scientific Title | 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 | 2025/02/13 09:21:38 |
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Basic information
Public title
Diagnostic accuracy of MRI in lateral pelvic lymph node metastasis of rectal cancer
Acronym
Diagnostic accuracy of MRI in lateral pelvic lymph node metastasis of rectal cancer
Scientific Title
Diagnostic accuracy of MRI in lateral pelvic lymph node metastasis of rectal cancer
Scientific Title:Acronym
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
1) A case with a contraindication for MRI, such as use of artificial devices (e.g., cardiac pacemaker)
2) A case wherein assessing the status of LLN metastasis on MRI imaging is difficult because of intrapelvic artifacts
3) A case with an intrapelvic neoplasm, barring colorectal cancer, such as prostate cancer, bladder cancer, uterine cancer, and ovarian cancer.
4) A patient who is deemed to be inappropriate for study enrolment by the principal investigator or researcher
Target sample size
272
Research contact person
Name of lead principal investigator
| 1st name | Kazushige |
| Middle name | |
| Last name | Kawai |
Organization
The University of Tokyo
Division name
Department of Surgical Oncology
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
TEL
+81-3-3815-5411
kz-kawai@mvd.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Kazushie |
| Middle name | |
| Last name | Kawai |
Organization
The University of Tokyo
Division name
Department of Surgical Oncology
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
+81-3-3815-5411
Homepage URL
kz-kawai@mvd.biglobe.ne.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
the University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
Tel
+81-3-3815-5411
IRBjimu-tokyo@umin.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
| 2018 | Year | 08 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038428
