UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053640 |
|---|---|
| Receipt number | R000061224 |
| Scientific Title | A prospective observational study on high-risk factors for Stage II colorectal cancer |
| Date of disclosure of the study information | 2024/02/18 |
| Last modified on | 2024/03/24 17:30:05 |
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Basic information
Public title
A prospective observational study on high-risk factors for Stage II colorectal cancer
Acronym
A study on high-risk factors for Stage II colorectal cancer
Scientific Title
A prospective observational study on high-risk factors for Stage II colorectal cancer
Scientific Title:Acronym
A prospective observational study on high-risk factors for Stage II colorectal cancer
Region
| Japan |
Condition
Condition
pathological stage II colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to extract a high-risk group for recurrence of pathological stage II colorectal cancer from a prospective cohort of patients who underwent curative resection.
Basic objectives2
Others
Basic objectives -Others
Using factors determinable through routine hematological tests and pathological examination methods, we aim to prospectively validate the high-risk group for pathological stage II colorectal cancer.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
3-year relapse-free survival
Key secondary outcomes
3-year overall survival, 5-year relapse-free survival, 5-year overall survival
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
1) The histopathological diagnosis of the surgical specimen confirms adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and medullary carcinoma) according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma.
2) The primary site determined by surgical findings is diagnosed as ranging from the cecum to the rectum or anal canal (C, A, T, D, S, RS, Ra, Rb, P) according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma.
3) R0 resection has been performed.
4) The stage is classified as (y)pStage II according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma.
5) The age at registration is 20 years or older.
6) An adequate explanation of the study has been provided, and written informed consent has been obtained from the participants.
Key exclusion criteria
1) Presence of active double cancer (simultaneous double cancer/multiple primary cancers and metachronous double cancer/multiple primary cancers with a disease-free period of <five years.
2) Colorectal cancer associated with ulcerative colitis or Crohn's disease.
3) Colorectal cancer associated with familial adenomatous polyposis.
4) Some adenocarcinomas contain histological types different from adenocarcinoma (such as squamous cell carcinoma, neuroendocrine carcinoma).
5) Other reasons deemed inappropriate for registration by the attending physician for this study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | AKIYOSHI |
Organization
Cancer Institute Hospital
Division name
Department of Colorectal Surgery
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
+81335200111
takashi.akiyoshi@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Tatsuki |
| Middle name | |
| Last name | Noguchi |
Organization
Cancer Institute Hospital
Division name
Department of Colorectal Surgery
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
+81335200111
Homepage URL
tatsuki.noguchi@jfcr.or.jp
Sponsor or person
Institute
Japanese Society for Cancer of the Colon and Rectum
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital
Address
3-8-31, Ariake, Koto-ku, Tokyo
Tel
+81335200111
3-8-31, Ariake, Koto-ku
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
| 2024 | Year | 02 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to the pathological factors included in the diagnostic criteria of the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (histological type, lymphatic invasion, venous invasion, perineural invasion, depth of invasion, etc.), we will also prospectively evaluate 4 additional pathological factors not included in the diagnostic criteria of the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (tumor budding, poorly differentiated clusters, desmoplastic reaction, and POR graded according to the x40 objective lens rule).
Management information
Registered date
| 2024 | Year | 02 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061224
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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