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

Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Screening

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

• Study Type: Observational
• Enrollment (Actual): 276

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 14021
    • Institute for Clinical and Experimental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinics, university hospitals, private practices

Description

Inclusion Criteria:

• newly diagnosed colorectal cancer

Exclusion Criteria:

• unsigned informed consent
• mental disorder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
Non-screening Group; Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal Cancer Stage (pTNM)	Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group.; 0. stage (Tis N0 M0); I. stage (T1-2 N0 M0); II. stage (T3-4 N0 M0); III. stage (T1-4 N1-2 M0); IV. stage (T1-4 N1-2 M1) Stages 0,I II were considered to have better outcome	at time of diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal Cancer Grade	Differences between colorectal cancer grade in screening vs. non-screening group.; GX (cannot be identified); G1 (well diff.); G2 (moderately diff.); G3 (poorly diff.); G4 (undifferentiated) Grades 1,2 were considered to have connection with lower stage	after surgery was performed
Colorectal Cancer Resection Margins	Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group.; RX: cannot be identified; R0: no cancer cells seen microscopically at the resection margin; R1: cancer cells present microscopically at the resection margin (microscopic positive margin); R2: gross examination by the naked eye shows tumor tissue present at the resection margin (macroscopic positive margin)	after surgery was performed
Colorectal Cancer Metastasis	Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.; MX: cannot be measured; M0: cancer has not spread to other parts of the body; M1: cancer has spread to other parts of the body	at time of diagnosis
Colorectal Cancer Surgery	Median time between diagnosis and surgery.	time between diagnosis and surgery, measured after surgery was performed
Colorectal Cancer and Palliative Therapy	Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group. Number of patients treated with palliative therapy in both groups.	during treatment plan setting

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine
• Collaborators: Brno University Hospital; Tomas Bata Hospital, Czech Republic; Masaryk Hospital Usti nad Labem; Military University Hospital, Prague; Vitkovice Hospital; Private practice at Hluboká nad Vltavou; Klaudian Hospital Mladá Boleslav; Medic Kral Ltd.; Chomutov Hospital; Frýdek-Místek Hospital; The University Hospital Plzeň
• Investigators: Principal Investigator: Jan Král, M.D., Institute for Clinical and Experimental Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 3, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Screening; Chemotherapy; Colorectal Cancer; Metastasis; pTNM; Resection Margins
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 00023001-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO