Colorectal Cancer: Screening vs. Non-Screening

NCT ID: NCT02727894

Last Updated: 2019-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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

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Colorectal Cancer Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screening Group

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

No interventions assigned to this group

Non-screening Group

Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* newly diagnosed colorectal cancer

Exclusion Criteria

* unsigned informed consent
* mental disorder
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Private practice at Hluboká nad Vltavou

UNKNOWN

Sponsor Role collaborator

Klaudian Hospital Mladá Boleslav

UNKNOWN

Sponsor Role collaborator

Masaryk Hospital Usti nad Labem

OTHER

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

Medic Kral Ltd.

UNKNOWN

Sponsor Role collaborator

Chomutov Hospital

UNKNOWN

Sponsor Role collaborator

Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role collaborator

Military University Hospital, Prague

OTHER

Sponsor Role collaborator

Frýdek-Místek Hospital

UNKNOWN

Sponsor Role collaborator

The University Hospital Plzeň

UNKNOWN

Sponsor Role collaborator

Vitkovice Hospital

OTHER

Sponsor Role collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jan Král, MD

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Král, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical and Experimental Medicine

Locations

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Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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00023001-2015

Identifier Type: -

Identifier Source: org_study_id

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