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

NCT06454071 | Completed Phase 2

• 1 other identifier: Soonchunhyang UH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Colon; Interleukins; Aged

Outcome Measures

Primary Outcomes (1)

• Differences of recovery in between elderly and elderly patients

  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

Study Arms (2)

Interleukin6

OTHER

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

NK cell

OTHER

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

Interventions

Blood test OTHER

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.

Interleukin6; NK cell

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Byeo Lee Lim, Dr

  Soonchunhyang University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The entire number of patients was divided into elderly and non-elderly groups based on the age of 70. 29 patients were assigned in elderly group, and 46 patients were assigned in non-elderly group. Preoperative blood sampling including WBC, lymphocyte, neutrophil, albumin, globulin was performed for all patients. In case of participants, investigators added the additional blood tests including immunologic markers including Interleukin-6 and Natural killer cell. These blood tests including immunologic markers were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery)

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 12, 2024
• Study Start: September 4, 2023
• Primary Completion: February 2, 2024
• Study Completion: May 29, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-05

Locations

KR (1)