UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053166 |
|---|---|
| Receipt number | R000060674 |
| Scientific Title | Prognostic value of systemic inflammation score in patients with esophageal cancer |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/19 22:41:32 |
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Basic information
Public title
Prognostic value of systemic inflammation score in patients with esophageal cancer
Acronym
Prognostic value of systemic inflammation score in patients with esophageal cancer
Scientific Title
Prognostic value of systemic inflammation score in patients with esophageal cancer
Scientific Title:Acronym
Prognostic value of systemic inflammation score in patients with esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted this retrospective study in a cohort of esophageal cancer patients undergoing potentially curative resection and clarified that SIS may improve the prognostic accuracy for clinical outcomes in esophageal cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association with recurrence and SIS.
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
This retrospective cohort study included 32 patients who underwent thoracoscopic esophagectomy after neoadjuvant chemotherapy for esophageal cancer at the Department of Surgery of the Nagasaki Medical Center (Omura, Japan) between January 2016 and December 2019.
Key exclusion criteria
None
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Yoneda |
Organization
NHO Nagasaki Medical Center
Division name
Department of Surgery
Zip code
856-0835
Address
2-1001-1 Kubara, Omura, Nagasaki
TEL
+81-957-52-3121
akira-br@infoseek.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yoneda |
Organization
NHO Nagasaki Medical Center
Division name
Department of Surgery
Zip code
856-0835
Address
2-1001-1 Kubara, Omura, Nagasaki
TEL
+81-957-52-3121
Homepage URL
akira-br@infoseek.jp
Sponsor or person
Institute
NHO Nagasaki Medical Center
Institute
Department
Personal name
Akira Yoneda
Funding Source
Organization
NHO Nagasaki Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
NHO Nagasaki Medical Center
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Nagasaki Medical Center
Address
2-1001-1 Kubara, Omura, Nagasak
Tel
0957523121
akira-br@infoseek.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 | 20 | 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
32
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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples were collected within one week prior to the initiation of preoperative chemotherapy. Three inflammatory and nutritional markers-SIS, NLR and PNI were examined in this study. LMR was calculated by dividing the absolute number of circulating lymphocytes by the absolute number of circulating monocytes. The SIS was defined according to the methods of a previous report, using a combination of the LMR and serum albumin concentration: patients Disease free survival was assessed using the Kaplan Meier method, and univariate and multivariate Cox models were used to evaluate the predictive value of SIS, NLR and PNI.
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060674
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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