Immunologic Changes and Recovery-related Factors in Elderly Colon Cancer Patients

June 11, 2024 updated by: Soonchunhyang University Hospital

Relationship Between Immunologic Changes and Recovery-related Factors in the Recovery Process of Elderly Colon Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (POD#3), and outpatient clinic day (about postoperative 21th day (POD#21)). 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 < 41cm2/m2 in women and SMI < 43 cm2/m2 in men with a body mass index (BMI) < 25kg/m2, and < 53 cm2/m2 in men with a BMI ≥ 25 kg/m2.

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • colon cancer patients treated with surgery
  • diagnosed with adenocarcinoma histologically
  • having information regarding preoperative status with abdominopelvic CT

Exclusion Criteria:

  • familial colorectal cancer
  • malignancies other than adenocarcinoma
  • inflammatory bowel disease-associated cancer
  • recurrence
  • metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interleukin6
Immunologic tests including Interleukin 6 were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery). The IL-6 tests were carried out in our hospital.
Other: Blood test
Immunologic tests including Interleukin 6 were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery). The IL-6 tests and NK cells were carried out in our hospital.
Other: NK cell
Immunologic tests including Nk cell were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery). The NK cell tests were carried out in our hospital. Peripheral blood mononuclear cells were evaluated using flow cytometry via fluorochrome-conjugated antibodies against a number of NK cell receptors.
Other: Blood test
Immunologic tests including Interleukin 6 were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery). The IL-6 tests and NK cells were carried out in our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences of recovery in between elderly and elderly patients
Time Frame: up to 1 month
The primary end point was' recovery' represented by hospital stay. Investigators evaluated 'Recovery' by hospital stay and readmission within 30 days after discharge. Investigators categorized the patients who had a shorter-than-average hospital stay as 'fast' group, and patietns who had a longer-than-average hospital stay or readmitted within 30 days after discharge rated their recovery as 'slow' group.
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

  • Study Director: Byeo Lee Lim, Dr, Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

May 29, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soonchunhyang UH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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