Colorectal CancerNCT06704646
Predictors of One-Year Mortality After Curative Surgery in Patients Aged 80 Years or Older With Non-Metastatic Colorectal Cancer
An observational study of Colorectal Cancer, run by National Taiwan University Hospital.
Trial summary
The aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Curative intent surgery
- Type of treatment
- Surgery or procedure
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2020
- Phase
- Observational
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This retrospective study was performed at National Taiwan University hospital. Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019, and they were followed up until December 31, 2020. Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study.
Who may be able to join
- Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019
Who cannot join
- Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study
About this study
The aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.
Read the detailed description
Colorectal cancer is common among older adults, and with the aging global population, the number of elderly individuals diagnosed with this condition continues to rise. Current treatment guidelines identify surgery as the primary approach for managing non-metastatic colorectal cancer. Previous studies have shown that factors like advanced age, frailty, comorbidities, and nutritional status can predict surgical outcomes. However, in patients over 80 years old with non-metastatic colorectal cancer, questions remain regarding the definition of advanced age and frailty, the applicability of existing assessment tools to this specific group, and the determination of optimal cut-off values, all of which require further validation. Furthermore, there is a shortage of effective outpatient screening tools to identify vulnerable patients and provide reliable guidance for predicting postoperative survival. Therefore, the aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.
- Conditions
- Colorectal Cancer
- Being tested
- Curative intent surgery
- Keywords
- Colorectal cancer, Geriatrics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative intent surgeryProcedure or surgery
Curative intent surgery means that surgeons intend to perform R0 resection.
| Study group | Role | What they receive |
|---|---|---|
| Patients passed away within one year | Records their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index. We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging Receives: Procedure: Curative intent surgery | |
| Patient survived the first post-operative year | Records their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index. We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging Receives: Procedure: Curative intent surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative factors associated with one-year postoperative mortality
Univariate and multivariable logistic regression analysis were performed to identify preoperative factors associated with one-year postoperative mortality.
Measured: From operation to one year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704646
- Sponsor's protocol ID
- 202003045RINB
- Status last verified
- Dec 2020
- First submitted
- 21 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27.
PubMed 31455888Chen B, Yu W, Ma Y, Xu P, Yao Q, Sun Q, Ren J, Wang D. Evaluation of the safety and efficacy of perform enterectomy in colorectal cancer patients aged 80 or older. A meta-analysis and a systematic review. Int J Colorectal Dis. 2023 Jul 3;38(1):185. doi: 10.1007/s00384-023-04461-2.
PubMed 37395836Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.
PubMed 21445672
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of One-Year Mortality After Curative Surgery in Patients Aged 80 Years or Older With Non-Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06704646
- Acronym / sponsor ID
- 202003045RINB
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Geriatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Nov 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.
The aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.
Detailed description
Colorectal cancer is common among older adults, and with the aging global population, the number of elderly individuals diagnosed with this condition continues to rise. Current treatment guidelines identify surgery as the primary approach for managing non-metastatic colorectal cancer. Previous studies have shown that factors like advanced age, frailty, comorbidities, and nutritional status can predict surgical outcomes. However, in patients over 80 years old with non-metastatic colorectal cancer, questions remain regarding the definition of advanced age and frailty, the applicability of existing assessment tools to this specific group, and the determination of optimal cut-off values, all of which require further validation. Furthermore, there is a shortage of effective outpatient screening tools to identify vulnerable patients and provide reliable guidance for predicting postoperative survival. Therefore, the aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients passed away within one year | – | Procedure: Curative intent surgeryRecords their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index. We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging |
| Patient survived the first post-operative year | – | Procedure: Curative intent surgeryRecords their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index. We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This retrospective study was performed at National Taiwan University hospital. Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019, and they were followed up until December 31, 2020. Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study.
Key inclusion criteria (1 listed)
- Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019
Key exclusion criteria (1 listed)
- Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study
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 |
|---|---|---|
| Curative intent surgeryCurative intent surgery means that surgeons intend to perform R0 resection. | Procedure or surgery | Patient survived the first post-operative year, Patients passed away within one year |
Primary outcome
Preoperative factors associated with one-year postoperative mortality
Time frame: From operation to one year after the surgery
Univariate and multivariable logistic regression analysis were performed to identify preoperative factors associated with one-year postoperative mortality.
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 27 Nov 2024.
- Background: PubMed 31455888Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27.
- Background: PubMed 37395836Chen B, Yu W, Ma Y, Xu P, Yao Q, Sun Q, Ren J, Wang D. Evaluation of the safety and efficacy of perform enterectomy in colorectal cancer patients aged 80 or older. A meta-analysis and a systematic review. Int J Colorectal Dis. 2023 Jul 3;38(1):185. doi: 10.1007/s00384-023-04461-2.
- Background: PubMed 21445672Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by National Taiwan University Hospital.
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 1 inclusion and 1 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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Preoperative factors associated with one-year postoperative mortality (time frame: From operation to one year after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704646, which also lists 3 linked publications.
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 27 Nov 2024.