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

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.

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients

Time frame: 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.
Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients

Time frame: 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.
Proportions of treatment given to patients with locoregionally recurrent colon cancer

Time frame: 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.
Overall survival of patients with locoregionally recurrent colon cancer;

Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer: a Retrospective, Population-based Cohort Study

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jul 26, 2022
Registry last updated: Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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