Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Institute for Clinical and Experimental Medicine
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Colorectal Cancer Stage (pTNM)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Jan Král, MD
M.D.
Institute for Clinical and Experimental Medicine
Eligibility Criteria
Inclusion Criteria
- •newly diagnosed colorectal cancer
Exclusion Criteria
- •unsigned informed consent
- •mental disorder
Outcomes
Primary Outcomes
Colorectal Cancer Stage (pTNM)
Time Frame: 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 Outcomes
- Colorectal Cancer Grade(after surgery was performed)
- Colorectal Cancer Surgery(time between diagnosis and surgery, measured after surgery was performed)
- Colorectal Cancer and Palliative Therapy(during treatment plan setting)
- Colorectal Cancer Resection Margins(after surgery was performed)
- Colorectal Cancer Metastasis(at time of diagnosis)