Clinical trial NCT02727894: Colorectal Cancer: Screening vs. Non-Screening
Official title: Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Screening
Keywords: Screening
pTNM
Metastasis
Chemotherapy
Resection Margins
Colorectal Cancer
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Private practice at Hluboká nad Vltavou
name: Klaudian Hospital Mladá Boleslav
name: Masaryk Hospital Usti nad Labem
name: Brno University Hospital
name: Medic Kral Ltd.
name: Chomutov Hospital
name: Tomas Bata Hospital, Czech Republic
name: Military University Hospital, Prague
name: Frýdek-Místek Hospital
name: The University Hospital Plzeň
name: Vitkovice Hospital
First posted: 2016-04-05
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinics, university hospitals, private practices

Brief 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

Eligibility criteria: Inclusion Criteria:

* newly diagnosed colorectal cancer

Exclusion Criteria:

* unsigned informed consent
* mental disorder

Primary outcomes:
measure: Colorectal Cancer Stage (pTNM)
timeFrame: at time of diagnosis
Secondary outcomes:
measure: Colorectal Cancer Grade
timeFrame: after surgery was performed
measure: Colorectal Cancer Resection Margins
timeFrame: after surgery was performed
measure: Colorectal Cancer Metastasis
timeFrame: at time of diagnosis
measure: Colorectal Cancer Surgery
timeFrame: time between diagnosis and surgery, measured after surgery was performed
measure: Colorectal Cancer and Palliative Therapy
timeFrame: during treatment plan setting
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Jan Král, M.D.
role: PRINCIPAL_INVESTIGATOR
References: