Colorectal Cancer: Screening vs. Non-Screening

Colorectal Cancer Clinical Trial

— CRC  

Official title:

Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727894
• Other study ID #: 00023001-2015
• Status: Completed
• Start date: March 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2019
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• newly diagnosed colorectal cancer

Exclusion Criteria:

• unsigned informed consent

• mental disorder

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Screening

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Praha

Sponsors (12)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Brno University Hospital, Chomutov Hospital, Frýdek-Místek Hospital, Klaudian Hospital Mladá Boleslav, Masaryk Hospital Rakovník, Medic Kral Ltd., Military University Hospital, Prague, Private practice at Hluboká nad Vltavou, The University Hospital Plzen, Tomas Bata Hospital, Czech Republic, Vitkovice Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Colorectal Cancer Surgery	Median time between diagnosis and surgery.	time between diagnosis and surgery, measured after surgery was performed
Secondary	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