UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053007 |
|---|---|
| Receipt number | R000060468 |
| Scientific Title | Clinicopathological features of locally recurrent rectal cancer in Japan: a nationwide cohort database |
| Date of disclosure of the study information | 2023/12/05 |
| Last modified on | 2023/12/05 19:24:55 |
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Basic information
Public title
Clinicopathological features of locally recurrent rectal cancer in Japan: a nationwide cohort database
Acronym
Clinicopathological features of locally recurrent rectal cancer in Japan: a nationwide cohort database
Scientific Title
Clinicopathological features of locally recurrent rectal cancer in Japan: a nationwide cohort database
Scientific Title:Acronym
Clinicopathological features of locally recurrent rectal cancer in Japan: a nationwide cohort database
Region
| Japan |
Condition
Condition
locally recurrent rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinicopathological features and outcomes of locally recurrent rectal cancer in Japan from a nationwide cohort database.
Basic objectives2
Others
Basic objectives -Others
To identify the impact of imaging findings and pathologic factors on the outcome of locally recurrent rectal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the long-term outcomes of the patients with locally recurrent rectal cancer by treatment modality.
Key secondary outcomes
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. Patients with a clinical or pathological diagnosis of locally recurrent rectal cancer between January 1, 2011 and July 31, 2023.
2. Local recurrence after R0/1 excision.
3.Previous radiotherapy or chemotherapy for rectal cancer, distant metastasis, or resection of metastases are not included.
Key exclusion criteria
1. Patients who refuse to participate in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kay |
| Middle name | |
| Last name | Uehara |
Organization
Nippon Medical School
Division name
GI and HBP Surgery
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
kueharam123185m@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Sando |
Organization
Nagoya Ekisaikai Hospital
Division name
Surgery
Zip code
454-8502
Address
Shonen-cho 4-66, Nakagawa-ku, Nagoya city
TEL
052-652-7711
Homepage URL
masanori.sando@hotmail.com
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Ethical Committee
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 05 | 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
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multi-center retrospective study
Management information
Registered date
| 2023 | Year | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060468
