Clinical Trials Directory

Trials / Completed

CompletedNCT02727894

Colorectal Cancer: Screening vs. Non-Screening

Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes

Status
Completed
Phase
Study type
Observational
Enrollment
276 (actual)
Sponsor
Institute for Clinical and Experimental Medicine · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.

Detailed description

Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee. All participants gave their informed signed consent. Each centre was assigned a unique ID number to distinguish between the locations in which patients were enrolled. Patients informations were stored under identification number in secure internet database (RedCap) run by The International Clinical Research Center of St. Anne's University Hospital Brno.REDCap is a secure, web-based application designed to support data capture for research studies. Statistical analysis was done with SAS, ver. 9.3. Descriptive statistics such as absolute and relative frequencies and median with 95 % confidence intervals were used. Differences between the screening and non-screening groups were compared using the Chi-square test or Fisher's exact test (categorical parameters) and Mann-Whitney test (continuous parameters). Results with a p-value \< 0.05 were considered statistically significant

Conditions

Timeline

Start date
2013-03-01
Primary completion
2015-12-01
Completion
2016-01-01
First posted
2016-04-05
Last updated
2019-03-05
Results posted
2019-03-05

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT02727894. Inclusion in this directory is not an endorsement.