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Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05475288
Collaborator
(none)
3,554
Enrollment
5.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3554 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer: a Retrospective, Population-based Cohort Study
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jun 30, 2015
    Actual Study Completion Date :
    Jun 30, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients [Three years]

      UNIT OF MEASUREMENT: Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients; MEASUREMENT TOOL: Registration of diagnosis of locoregionally recurrent colon cancer in the electronic patient file. The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locoregionally recurrent colon cancer at that time point.

    2. Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients [Three years]

      UNIT OF MEASUREMENT: Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients; MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary colon cancer in the electronic patient file and national pathological database (PALGA). Clinical and pathological risk factors for the development of locoregionally recurrent colon cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locoregionally recurrent colon cancer.

    3. Proportions of treatment given to patients with locoregionally recurrent colon cancer [Three years]

      UNIT OF MEASUREMENT: Proportions of treatment given to patients with locoregionally recurrent colon cancer; MEASUREMENT TOOL: Registration of treatment for locoregionally recurrent colon cancer in the electronic patient file. Using descriptive statistics, treatment patterns of patients with locoregionally recurrent colon cancer will be identified. Groups that will be created, will also be used to assess overall survival.

    4. Overall survival of patients with locoregionally recurrent colon cancer; [Three years]

      UNIT OF MEASUREMENT: Overall survival of patients with locoregionally recurrent colon cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database. Overall survival will be estimated for patients with locoregionally recurrent colon cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed stage I-III primary colon carcinoma;

    • Diagnosed between January 1st and June 30th of 2015;

    • Surgical resection of primary colon carcinoma.

    Exclusion Criteria:

    • Appendiceal localization;

    • Neuroendocrine tumor morphology;

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hidde Swartjes, Researcher in training, Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05475288
    Other Study ID Numbers:
    • K20.306
    First Posted:
    Jul 26, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Colonic Neoplasms
    Neoplasm Recurrence, Local
    Recurrence

    Study Results

    No Results Posted as of Jul 26, 2022