UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042910 |
|---|---|
| Receipt number | R000048984 |
| Scientific Title | Validation of Clinical Value of the Treatment Strategies for T1 Colorectal Cancer (CRC) in the JSCCR Guidelines and Development of Predictive Model (Nomogram) for Lymph Node Metastasis in T1 CRC |
| Date of disclosure of the study information | 2021/01/23 |
| Last modified on | 2023/07/14 16:50:28 |
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Basic information
Public title
Establishment of Optimal Risk Assessment of Lymph Node Metastasis in T1 Colorectal Cancer by the Japanese Society for Cancer of the Colon and Rectum (JSCCR)
Acronym
JSCCR-T1 Study
Scientific Title
Validation of Clinical Value of the Treatment Strategies for T1 Colorectal Cancer (CRC) in the JSCCR Guidelines and Development of Predictive Model (Nomogram) for Lymph Node Metastasis in T1 CRC
Scientific Title:Acronym
T1-Nomogram
Region
| Japan |
Condition
Condition
pT1 colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Since the publication of the JSCCR guidelines 2009 for the treatment of colorectal cancer (CRC), the algorithm for pT1 tumor based on the five pathological risk factors of lymph node metastasis (LNM; vertical margin, depth of submucosal invasion, lympho-vascular invasion, tumor grade, and budding) is widely used in deciding additional laparotomy after local excision in Japan. On the other hand, it is acknowledged that this algorithm may cause the issue of "over-surgery" when we regard these factors evenly as absolute indications of surgery. Thus, development of highly accurate LNM predictive models are needed, which allows us to determine the indication of surgery depending on the specific degree of individual patient's risk. In this study, we establish multicenter databases of pT1 CRC treated after the year 2009, consisting prospectively diagnosed data on risk factors. Herewith, we verify the current algorithm adopted in the JSCCR guidelines and develop a nomogram for predicting the LNM risk of individual pT1 CRC patients.
Basic objectives2
Others
Basic objectives -Others
Development of Predictive Model (Nomogram) for Lymph Node Metastasis in T1 CRC
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Calculation tools of lymph node metastatic risk using Nomogram in pT1 colorectal cancer
Key secondary outcomes
Validation of Clinical Value of the Treatment Strategies for T1 Colorectal Cancer in the JSCCR Guidelines
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pT1 colorectal cancers which completely resected by endoscopic or surgical treatment between July 2009 and December 2016
Key exclusion criteria
Colitic cancer
Familial adenomatous polyposis
Synchronous or metachronous (within 5 years) multiple colorectal cancer other than carcinoma in situ
Comorbidity of active malignant tumor excluding colorectal cancer
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ueno |
Organization
National Defense Medical College
Division name
Dept. of Surgery
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
04-2995-1637
ueno_surg1@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kajiwara |
Organization
National Defense Medical College
Division name
Dept. of Surgery
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
04-2995-1637
Homepage URL
http://www.jsccr.jp/project/proj_pt1.html
ykaji@ndmc.ac.jp
Sponsor or person
Institute
Japanese Society for Cancer of the Colon and Rectum
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Cancer of the Colon and Rectum
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional review board of JSCCR
Address
Sanbancho KS Bldg., 2 Sanbancho, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-8697
jsccr@secretariat.ne.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
愛知県がんセンター（愛知県）
秋田赤十字病院消化器病センター（秋田県）
岩手医科大学附属病院（岩手県）
がん研有明病院（東京都）
久留米大学病院（福岡県）
呉医療センター・中国がんセンター（広島県）
国立がん研究センター中央病院（東京都）
国立がん研究センター東病院（千葉県）
静岡県立静岡がんセンター（静岡県）
順天堂大学医学部附属順天堂医院（東京都）
市立旭川病院消化器病センター（北海道）
大腸肛門病センター高野病院（熊本県）
東京医科歯科大学医学部附属病院（東京都）
東京医科大学病院（東京都）
東京医療センター（東京都）
東京大学医学部附属病院（東京都）
東京都立広尾病院（東京都）
東北大学病院（宮城県）
栃木県立がんセンター（栃木県）
獨協医科大学埼玉医療センター（埼玉県）
日本医科大学付属病院（東京都）
広島市立安佐市民病院（広島県）
広島大学病院（広島県）
兵庫医科大学病院（兵庫県）
福島県立医科大学会津医療センター（福島県）
防衛医科大学校病院（埼玉県）
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0016510723000263?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0016510723000263?via%3Dihub
Number of participants that the trial has enrolled
6105
Results
Six independent risk factors for LNM, including submucosal invasion depth and tumor budding, were identified in the development cohort and entered into a nomogram. The concordance index was 0.784 for the clinical calculator in the development cohort and 0.790 in the validation cohort. The calibration curve approached the 45-degree diagonal in the validation cohort.
Results date posted
| 2023 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 18 | Day |
Baseline Characteristics
Data from 4673 patients with T1 CRC treated at 27 high-volume institutions between 2009 and 2016 were analyzed for LNM risk.
Participant flow
N/A
Adverse events
N/A
Outcome measures
independent risk factors for lymph node metastasis in T1 CRC
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
In this study, we verify the current algorithm adopted in the JSCCR guidelines and develop a nomogram for predicting the LNM risk of individual pT1 CRC patients.
Management information
Registered date
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048984
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