UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047600 |
|---|---|
| Receipt number | R000054280 |
| Scientific Title | A retrospective observational study on the method of determining the extent of lymph node dissection using 3D-CTA in splenic flexure colon carcinoma |
| Date of disclosure of the study information | 2022/04/27 |
| Last modified on | 2024/04/28 09:05:43 |
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Basic information
Public title
A retrospective observational study on the method of determining the extent of lymph node dissection using 3D-CTA in splenic flexure colon carcinoma
Acronym
A retrospective observational study on the method of determining the extent of lymph node dissection using 3D-CTA in splenic flexure colon carcinoma
Scientific Title
A retrospective observational study on the method of determining the extent of lymph node dissection using 3D-CTA in splenic flexure colon carcinoma
Scientific Title:Acronym
A retrospective observational study on the method of determining the extent of lymph node dissection using 3D-CTA in splenic flexure colon carcinoma
Region
| Japan |
Condition
Condition
Splenic flexure colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the extent of lymph node dissection determined using preoperative 3D computed tomography angiography, in the management of splenic flexure colon cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 year overall survival rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Splenic flexure colon cancer
Laparoscopic surgery
Preoperative 3D-CTA
Key exclusion criteria
Emergency surgery
Palliative surgery
Laparotomy
Cases in which preoperative 3D-CTA could not be performed due to contrast allergy or renal dysfunction
Active multiple cancers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamagishi |
Organization
Fujisawa City Hospital
Division name
Department of surgery
Zip code
251-0052
Address
2-6-1 Fujisawa, Fujisawa, Kanagawa
TEL
0466253111
yamagishi-s@fujisawa-city-hospital.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Mori |
Organization
Fujisawa city hospital
Division name
Department of surgery
Zip code
251-8550
Address
2-6-1 Fujisawa, Fujisawa, Kanagawa
TEL
0466253111
Homepage URL
https://fujisawacity-hosp.jp/about/clinical-research.html
junkawashima0622@gmail.com
Sponsor or person
Institute
Fujisawa City Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujisawa City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujisawa City Hospital
Address
2-6-1 Fujisawa, Fujisawa, Kanagawa
Tel
0466253111
yamagishi-s@fujisawa-city-hospital.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
F2022003
Org. issuing International ID_1
Fujisawa City Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤沢市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
https://fujisawacity-hosp.jp/about/clinical-research.html
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ethical Considerations in Medical Research and Medical Practice
(1) Protection of the human rights of patients who are the subjects of medical research and medical treatment
In conducting this study, the ethical principles of the Declaration of Helsinki and the "Ethical Guidelines for Medical Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology/Ministry of Health, Labour and Welfare Notification No. 3 of 2014) (partially revised on February 28, 2017)" shall be observed, and the human rights, welfare, and safety of patients shall be secured to the greatest extent possible.
(2) Prediction of disadvantage, safety and contribution to patients caused by medical research and medical practice
This study is a retrospective study, and no disadvantage to patients will occur during the study period.
(3) Methods of explaining the details of medical research and medical treatment to patients and obtaining their consent
Since this is a retrospective observational study in which clinical and laboratory information will be collected from existing medical records, written consent is not required. However, the following information will, in principle, be disclosed on the website or poster of the department where the research subject is located prior to the start of the research, so that the subject can refuse to participate in the research.
(1) Outline of the research (subject, purpose, and methods), (2) Disclosure of the research, (3) Treatment of personal information, (4) Name of the research institution, (5) Name of the principal investigator, (6) Consultation service, and (7) Method to give research subjects the right to refuse to participate in the research.
(4) Measures necessary to protect personal information
When identifying patients, sufficient care will be taken to ensure that third parties cannot directly identify the patients.
Management information
Registered date
| 2022 | Year | 04 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054280
