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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000016909 |
Receipt No. | R000019607 |
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) |
Date of disclosure of the study information | 2015/03/25 |
Last modified on | 2015/03/25 |
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) |
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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) |
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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) |
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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) |
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Region |
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Condition | ||
Condition | Rectal cancer with rectal resection and lateral pelvic lymph node dissection | |
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
Age-lower limit |
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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). |
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Key exclusion criteria | No exclusion criteria | |||
Target sample size | 550 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
ykanemit@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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/ | ||||||
JCOG_sir@ml.jcog.jp |
Sponsor | |
Institute | Japan Clinical Oncology Group (JCOG) |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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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) |
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Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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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. |
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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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