Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454071
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Brief Title:
Immunologic Changes and Recovery-related Factors in Elderly Colon Cancer Patients
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
Relationship Between Immunologic Changes and Recovery-related Factors in the Recovery Process of Elderly Colon Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer is one of the most frequent malignancies with a rising proportion of elderly patients in an aging society In this study the investigators attempted to find out the relationship between immunologic factors and recovery using various parameters impacting the treatment in elderly patients
Detailed Description:
In prospective study total 75 patients who received radical resection for colon cancer between September 2023 and February 2024 at Asan Medical Center was involved Investigators included colon cancer patients treated with surgery diagnosed with adenocarcinoma histologically and having information regarding preoperative status with abdominopelvic CT Routine blood sampling and Immunologic tests including interleukin-6 IL-6 and natural killer cell NK cell were performed at preoperative day post operative 3rd day POD3 and outpatient clinic day about postoperative 21th day POD21 Investigators attempted to assess the patients subjective health level using a simple questionnaire EuroQol group- 5 dimension- 3 level EQ-5D-3L The sarcopenia was evaluated by the artificial intelligence software system and defined as an SMI 41cm2m2 in women and SMI 43 cm2m2 in men with a body mass index BMI 25kgm2 and 53 cm2m2 in men with a BMI 25 kgm2
In this study primary end point was recovery represented by hospital stay defined as the day from operation to discharge and readmission within 30days after discharge Secondary end point was EQ-5D-3L only in prospective cohort Recovery was evaluated by hospital stay and readmission within 30 days after discharge Analyses of clinicopathological characteristics of categorical variables and continuous variables were conducted using the chi-square test and t-test respectively A multivariable analysis with Cox proportional hazards model was used to compare risk factors associated with postoperative hospital day including NLR AGR albumin BMI and sarcopenia Investigators conducted an analysis including variables that have been proven to be related to the immune system or recovery in previous studies or that are suspected to be clinically relevant
In this study primary end point was recovery represented by hospital stay defined as the day from operation to discharge and readmission within 30days after discharge Secondary end point was EQ-5D-3L only in prospective cohort Recovery was evaluated by hospital stay and readmission within 30 days after discharge Analyses of clinicopathological characteristics of categorical variables and continuous variables were conducted using the chi-square test and t-test respectively A multivariable analysis with Cox proportional hazards model was used to compare risk factors associated with postoperative hospital day including NLR AGR albumin BMI and sarcopenia Investigators conducted an analysis including variables that have been proven to be related to the immune system or recovery in previous studies or that are suspected to be clinically relevant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None