Cancer of ColonPhase 2NCT06454071
Immunologic Changes and Recovery-related Factors in Elderly Colon Cancer Patients
A Phase 2 study testing Blood test in people with Cancer of Colon and Interleukins, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Cancer of Colon, Interleukins, Aged
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Sep 2023to 29 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colon cancer patients treated with surgery
- diagnosed with adenocarcinoma histologically
- having information regarding preoperative status with abdominopelvic CT
Who cannot join
- familial colorectal cancer
- malignancies other than adenocarcinoma
- inflammatory bowel disease-associated cancer
- recurrence
- metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer of Colon, Interleukins, Aged
- Being tested
- Blood test
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start4 Sep 2023
- Primary completion2 Feb 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeo Lee Lim, Dr, Study director, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454071
- Sponsor's protocol ID
- Soonchunhyang UH
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Immunologic Changes and Recovery-related Factors in the Recovery Process of Elderly Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT06454071
- Acronym / sponsor ID
- Soonchunhyang UH
- Conditions
- Cancer of Colon, Interleukins, Aged
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Interleukin6 | Other | Other: Blood testImmunologic 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. |
| NK cell | Other | Other: Blood testImmunologic 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- colon cancer patients treated with surgery
- diagnosed with adenocarcinoma histologically
- having information regarding preoperative status with abdominopelvic CT
Key exclusion criteria (5 listed)
- familial colorectal cancer
- malignancies other than adenocarcinoma
- inflammatory bowel disease-associated cancer
- recurrence
- metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testImmunologic 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 | Interleukin6, NK cell |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byeo Lee Lim, Dr study director
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blood test in people with Cancer of Colon and Interleukins, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of recovery in between elderly and elderly patients (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.