Colorectal Cancer: Screening vs. Non-Screening (CRC)

I

Institute for Clinical and Experimental Medicine

Status

Completed

Conditions

Screening
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02727894
00023001-2015

Details and patient eligibility

About

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.

Full 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

Enrollment

276 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • newly diagnosed colorectal cancer

Exclusion criteria

  • unsigned informed consent
  • mental disorder

Trial design

276 participants in 2 patient groups

Screening Group
Description:
CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test i(FOBT) in patients without symptoms invited to examination according to the national screening programme policy
Non-screening Group
Description:
Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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