UMIN-CTR Clinical Trial

Basic information
Public title	Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study)
Acronym	Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study)
Scientific Title	Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study)
Scientific Title:Acronym	Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study)
Region	Japan

Condition
Condition	Rectal cancer with rectal resection and lateral pelvic lymph node dissection
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Herein, we examine the relationship between preoperative factors (including imaging findings [CT/MRI], patient factors, and tumor factors) and the presence of pathological lateral lymph nodes metastasis in patients with rectal cancer undergoing rectal resection with lateral pelvic lymph node dissection. From these results, we identify the predicting factors for positive lateral pelvic lymph node metastasis, and determine the criteria of lateral pelvic lymph node positivity in the preoperative diagnosis.
Basic objectives2	Others
Basic objectives -Others	Observational Study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	False discovery rate (C/C+D)* regarding the diagnosis of lateral pelvic lymph node metastasis. (*: see below colum)
Key secondary outcomes	<1>False omission rate (B/A+B), positive predictive value (D/C+D), negative predictive value (A/A+B), sensitivity (D/B+D), and specificity (A/A+C) regarding the diagnosis of lateral pelvic lymph node metastasis. <2> False discovery rate (C/C+D), false omission rate (B/A+B), positive predictive value (D/C+D), negative predictive value (A/A+B), sensitivity (D/B+D), and specificity (A/A+C) regarding the diagnosis of lateral pelvic lymph node metastasis when adjusted for one or more patient and tumor factors (including gender, histological tumor type, invasion depth, lymph node metastasis in the mesorectum, and distance from the lower edge of the tumor to the anal verge, which were all determined as factors associated with lateral pelvic lymph node metastasis) and the size of the minor axis of the lateral pelvic lymph node in the imaging studies. <3> The differences between the central review result and the imaging diagnosis of each institution. A=preoperatively negative & pathologically negative B= preoperatively negative & pathologically positive C= preoperatively positive & pathologically negative D= preoperatively positive& pathologically positive

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
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Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Adenocarcinoma or adenosquamous carcinoma is pathologically diagnosed by preoperative biopsy. 2) Pelvic enhanced CT and MRI are performed for preoperative imaging (CT data of 1 mm/1.25 mm-thickness and 5 mm-thickness slices, and MRI data of 3 mm-thickness slices are required). 3) Satisfying either of the following criteria: the main tumor part is located either in the lower rectum or anal canal, or the lower edge of the tumor is located in the lower rectum. <1> The tumor invasion depth is deeper than T2. <2> Lateral pelvic lymph node metastasis is suspected by preoperative imaging. <3> Lymph node metastasis in the mesorectum is suspected by preoperative imaging. 4) Chemotherapy and radiotherapy to the rectal cancer is not performed before the operation, and lateral pelvic lymph node dissection is planned simultaneously with rectal resection. 5) There is no past history of operation, chemotherapy, and radiotherapy to intrapelvic tumors (rectal cancer, gynecologic cancer, urologic cancer, etc.). 6) There is no finding of distant organ metastasis, distant lymph node metastasis, and peritoneal dissemination in the preoperative imaging studies (except for cStage IV).
Key exclusion criteria	No exclusion criteria
Target sample size	550

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukihide Kanemitsu
Organization	National Cancer Center Hospital
Division name	Division of medical oncology
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
TEL	03-3542-2511
Email	ykanemit@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Satoshi Ikeda
Organization	JCOG1410-A Coordinating Office
Division name	Department of gastroenterology, Hiroshima Prefectural Hospital
Zip code
Address	5-54, Uzinakannda 1-Chome, Minami-Ku, Hiroshima 734-8530
TEL	082-254-1818
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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IRB Contact (For public release)
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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

札幌厚生病院（北海道） 岩手医科大学（岩手県） 宮城県立がんセンター（宮城県） 山形県立中央病院（山形県） 栃木県立がんセンター（栃木県） 防衛医科大学校（埼玉県） 埼玉県立がんセンター（埼玉県） 自治医科大学附属さいたま医療センター（埼玉県） 埼玉医科大学国際医療センター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 順天堂大学医学部附属浦安病院（千葉県） 国立がん研究センター中央病院（東京都） 杏林大学医学部（東京都） 東京医科大学病院（東京都） がん・感染症センター都立駒込病院（東京都） 慶應義塾大学病院（東京都） 東京医科歯科大学（東京都） 東邦大学医療センター大橋病院（東京都） 北里大学東病院（神奈川県） 神奈川県立がんセンター（神奈川県） 横浜市立市民病院（神奈川県） 北里大学医学部（神奈川県） 昭和大学横浜市北部病院（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 済生会横浜市南部病院（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 新潟県厚生連長岡中央綜合病院（新潟県） 石川県立中央病院（石川県） 長野市民病院（長野県） 岐阜大学医学部（岐阜県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 藤田保健衛生大学（愛知県） 大阪大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 大阪府立病院機構大阪府立急性期・総合医療センター（大阪府） 大阪医科大学（大阪府） 市立堺病院（大阪府） 箕面市立病院（大阪府） 市立吹田市民病院（大阪府） 関西労災病院（兵庫県） 兵庫医科大学（兵庫県） 医療法人薫風会佐野病院（兵庫県） 岡山済生会総合病院（岡山県） 広島市立広島市民病院（広島県） 県立広島病院（広島県） 広島市立安佐市民病院（広島県） 国立病院機構四国がんセンター（愛媛県） 高知医療センター（高知県） 久留米大学医学部（福岡県） 熊本大学医学部（熊本県） 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 25 Day
Last follow-up date	2016 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Herein, we examine the relationship between preoperative factors (including imaging findings [CT/MRI], patient factors, and tumor factors) and the presence of pathological lateral lymph nodes metastasis in patients with rectal cancer undergoing rectal resection with lateral pelvic lymph node dissection. From these results, we identify the predicting factors for positive lateral pelvic lymph node metastasis, and determine the criteria of lateral pelvic lymph node positivity in the preoperative diagnosis.

Management information
Registered date	2015 Year 03 Month 25 Day
Last modified on	2015 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019607

Research Plan
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Research case data specifications
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Research case data
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