UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052063 |
|---|---|
| Receipt number | R000059423 |
| Scientific Title | Postoperative adjuvant chemotherapy for colorectal cancer in sarcopenic patients |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/03/02 20:48:15 |
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Basic information
Public title
Efficacy and safety of postoperative adjuvant chemotherapy in colorectal cancer patients with sarcopenia: single-center retrospective observational study
Acronym
Postoperative adjuvant chemotherapy for colorectal cancer in sarcopenic patients
Scientific Title
Postoperative adjuvant chemotherapy for colorectal cancer in sarcopenic patients
Scientific Title:Acronym
Postoperative adjuvant chemotherapy for colorectal cancer in sarcopenic patients
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Sarcopenia is closely related to all diseases. We will exploratory examine preoperative skeletal muscle mass and the efficacy and safety of postoperative adjuvant chemotherapy in colorectal cancer patients, and use it as an index for the introduction of treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rate of postoperative adjuvant chemotherapy
Postoperative chemotherapy completion rate
Recurrence-free survival
Overall survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent resection surgery for colorectal cancer (adenocarcinoma of the colon and rectum) between January 1, 2015 and December 31, 2022 at the Department of Gastroenterology and General Surgery, Shimane University Hospital.
2.Patients who are eligible for postoperative adjuvant chemotherapy according to the colorectal cancer treatment guidelines
Key exclusion criteria
1.Patients without preoperative CT scan
2.Patients undergoing postoperative adjuvant chemotherapy at another hospital
3.Patients who have opted out and have been refused access to medical information by research subjects or their familiy
4.Patients with multiple cancers
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Taniura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
TEL
0853202232
taniura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Taniura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
TEL
0853202232
Homepage URL
https://rinken.shimane-u-tiken.jp/people/196
taniura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Taniura Takahito
Funding Source
Organization
Shimane University Faculty of Medicine
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
Tel
0853202259
kenkyu@med.shimane-u.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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059423
