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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02727894
Other study ID # 00023001-2015
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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