Colorectal Cancer: Screening vs. Non-Screening
- Conditions
- ScreeningColorectal Cancer
- Registration Number
- NCT02727894
- Lead Sponsor
- Institute for Clinical and Experimental Medicine
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- newly diagnosed colorectal cancer
- unsigned informed consent
- mental disorder
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Colorectal Cancer Stage (pTNM) at time of diagnosis 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
- Secondary Outcome Measures
Name Time Method Colorectal Cancer Resection Margins after surgery was performed 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)Colorectal Cancer Metastasis at time of diagnosis 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 bodyColorectal Cancer Grade after surgery was performed 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 stageColorectal Cancer Surgery time between diagnosis and surgery, measured after surgery was performed Median time between diagnosis and surgery.
Colorectal Cancer and Palliative Therapy during treatment plan setting Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group.
Number of patients treated with palliative therapy in both groups.
Trial Locations
- Locations (1)
Institute for Clinical and Experimental Medicine
🇨🇿Praha, Czechia