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 2019/02/26 17:08:44

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kazushie Kawai

Organization

The University of Tokyo

Division name

Department of Surgical Oncology

Zip code


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

1st name
Middle name
Last name Kazushie Kawai

Organization

The University of Tokyo

Division name

Department of Surgical Oncology

Zip code


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 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


Address


Tel


Email



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


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



Other

Other related information

Not applicable


Management information

Registered date

2018 Year 08 Month 09 Day

Last modified on

2019 Year 02 Month 26 Day



Link to view the page

Value
https://center6.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