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

NCT05475288 | Completed

• 1 other identifier: K20.306
• Study Type: observational
• Target: 3,554
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonic Neoplasms; Neoplasm Recurrence, Local

Outcome Measures

Primary Outcomes (4)

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

  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.

  Three years

• Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients

  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.

  Three years

• Proportions of treatment given to patients with locoregionally recurrent colon cancer

  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.

  Three years

• Overall survival of patients with locoregionally recurrent colon cancer;

  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.)

  Three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with stage I-III primary colon cancer in the first half of 2015.

You may qualify if:

• Histologically confirmed stage I-III primary colon carcinoma;
• Diagnosed between January 1st and June 30th of 2015;
• Surgical resection of primary colon carcinoma.

You may not qualify if:

• Appendiceal localization;
• Neuroendocrine tumor morphology;

Sponsors & Collaborators

• Radboud University Medical Center: lead

Related Publications (1)

• Swartjes H, van Lankveld DWP, van Erning FN, Verheul HMW, de Wilt JHW, Koeter T, Vissers PAJ. Locoregionally Recurrent Colon Cancer: How Far Have We Come? A Population-Based, Retrospective Cohort Study. Ann Surg Oncol. 2023 Mar;30(3):1726-1734. doi: 10.1245/s10434-022-12689-5. Epub 2022 Oct 19.

  PMID: 36261752 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in training

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 26, 2022
• Study Start: January 1, 2015
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share