Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475301
• Other study ID #: K20.256
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: June 30, 2015

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Data on disease recurrence was collected for all primary rectal 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 locally recurrent rectal cancer were determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1431
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed stage I-III primary rectal carcinoma;

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

• TME resection of primary rectal carcinoma.

Exclusion Criteria:

• Neuroendocrine tumor morphology;

Related Conditions & MeSH terms

• Neoplasm Recurrence, Local
• Neoplasms
• Rectal Neoplasms
• Recurrence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients	UNIT OF MEASUREMENT: Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients MEASUREMENT TOOL: Registration of diagnosis of locally recurrent rectal 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 locally recurrent rectal cancer at that time point.	Three years
Primary	Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients	UNIT OF MEASUREMENT: Risk factors for development of locally recurrent rectal cancer in primary rectal cancer patients MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary rectal cancer in the electronic patient file and national pathological database (PALGA).; Clinical and pathological risk factors for the development of locally recurrent rectal 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 locally recurrent rectal cancer.	Three years
Primary	Proportions of treatment given to patients with locally recurrent rectal cancer	UNIT OF MEASUREMENT: Proportions of treatment given to patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of treatment for locally recurrent rectal cancer in the electronic patient file.; Using descriptive statistics, treatment patterns of patients with locally recurrent rectal cancer will be identified. Groups that will be created, will also be used to assess overall survival.	Three years
Primary	Overall survival of patients with locally recurrent rectal cancer	UNIT OF MEASUREMENT: Overall survival of patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database.; Overall survival will be estimated for patients with locally recurrent rectal cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)	Three years