Colorectal Cancer: Screening vs. Non-Screening

Study Overview
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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

Official Title
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Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes

Conditions
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Colorectal Cancer, Screening

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed colorectal cancer Exclusion Criteria: unsigned informed consent mental disorder
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening Group<br>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<br>Symptomatic CRC was defined as cancer diagnosed in symptomatic patients. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resection Margins, Screening, pTNM, Metastasis, Chemotherapy, Colorectal Cancer