Survival Outcomes by Tumor-Node Stage and Recurrence Patterns in Colon Cancer After Radical Surgery
NCT ID: NCT07167147
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7259 participants
OBSERVATIONAL
2025-04-09
2025-08-01
Brief Summary
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This study retrospectively evaluates patients with stage I-III colon cancer who underwent radical surgery at Chang Gung Memorial Hospital between 2006 and 2018. A total of 7,259 patients are included from the institutional tumor registry. Patients are categorized into four tumor-node (TN) stage groups:
* T1-3 without lymph node involvement
* T1-3 with lymph node involvement
* T4 without lymph node involvement
* T4 with lymph node involvement
The study aims to examine recurrence patterns (no recurrence, local recurrence, isolated lung metastasis, isolated liver metastasis, or multiple sites) and overall survival. Statistical analyses planned include Kaplan-Meier survival analysis and marginal structural models to compare outcomes across different TN stages and recurrence types.
This study is based on retrospective data and was approved by the Institutional Review Board of Chang Gung Memorial Hospital (IRB No: 202500389B0). No new patient enrollment or interventions will be performed, and patient consent was waived due to the retrospective nature of the study.
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Detailed Description
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The objective of this study is to investigate the relationship between TN stage and recurrence patterns in patients with stage I-III colon adenocarcinoma who underwent radical surgery at Chang Gung Memorial Hospital, Taiwan. A retrospective cohort of 7,259 patients who had surgery between 2006 and 2018 is analyzed using data from the institutional tumor registry. Patients are categorized into four groups according to T and N status: T1-3N0, T1-3N+, T4N0, and T4N+.
Primary outcomes include recurrence patterns (local recurrence, isolated lung metastasis, isolated liver metastasis, multiple-site metastases, or no recurrence). The secondary outcome is overall survival, assessed both after surgery and after recurrence. Planned statistical analyses include multinomial logistic regression to evaluate recurrence risk by TN stage, Kaplan-Meier survival curves with log-rank tests to compare survival across recurrence types, and marginal structural models with inverse probability weighting to address time-dependent confounders and estimate causal effects of TN stage and recurrence on mortality risk.
This retrospective analysis was reviewed and approved by the Institutional Review Board of Chang Gung Memorial Hospital (IRB No: 202500389B0). Patient consent was waived because only de-identified registry data are used.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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T1-3N-
Patients with stage I-III colon adenocarcinoma, T1-3 tumors without lymph node involvement.
No interventions assigned to this group
T1-3N+
Patients with stage I-III colon adenocarcinoma, T1-3 tumors with lymph node involvement.
No interventions assigned to this group
T4N-
Patients with stage I-III colon adenocarcinoma, T4 tumors without lymph node involvement.
No interventions assigned to this group
T4N+
Patients with stage I-III colon adenocarcinoma, T4 tumors with lymph node involvement.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Stage I-III disease at diagnosis
* Underwent curative (radical) resection at Chang Gung Memorial Hospital between 2006 and 2018
* Availability of complete clinical, pathological, and follow-up data
Exclusion Criteria
* Non-adenocarcinoma histology (e.g., undifferentiated carcinoma, squamous cell carcinoma, lymphoma, sarcoma)
* History of other malignancies or synchronous multiple cancers
* Patients who underwent only palliative surgery or local excision
* Incomplete medical records or missing follow-up information
18 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taoyuan, Taiwan
Countries
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Other Identifiers
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202500389B0
Identifier Type: -
Identifier Source: org_study_id
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