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| Name | Class |
|---|---|
| Private practice at Hluboká nad Vltavou | UNKNOWN |
| Klaudian Hospital Mladá Boleslav | UNKNOWN |
| Masaryk Hospital Usti nad Labem | OTHER |
| Brno University Hospital |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening Group | 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 | Symptomatic CRC was defined as cancer diagnosed in symptomatic patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Stage (pTNM) | Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group.
Stages 0,I II were considered to have better outcome | at time of diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Grade | Differences between colorectal cancer grade in screening vs. non-screening group.
Grades 1,2 were considered to have connection with lower stage | after surgery was performed |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinics, university hospitals, private practices
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| Name | Affiliation | Role |
|---|---|---|
| Jan Král, M.D. | Institute for Clinical and Experimental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | 14021 | Czechia |
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Patients with diagnosed colorectal carcinoma were enrolled (276). 11 patients were excluded because of the inability to categorise those patients into the screening or non-screening group.
From March 2013 till September 2015 in 12 centres across the Czech Republic 276 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Screening Group | CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test (iFOBT) in patients without symptoms invited to examination according to the national screening programme policy |
| FG001 | Non-screening Group | Symptomatic CRC was defined as cancer diagnosed in symptomatic patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Screening | Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after FOBT). |
| BG001 | Others | Patients with colorectal cancer diagnosed by other diagnostic procedures (diagnostic colonoscopy, CT, magnetic resonance, ultrasonography, urgent surgery, etc.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Colorectal Cancer Stage (pTNM) | Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group.
Stages 0,I II were considered to have better outcome | Posted | Count of Participants | Participants | at time of diagnosis |
|
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Adverse event data were not collected because data were mainly obtained at the time of diagnosis or at the time of treatment plan setting.
Study was focused on comparing screening group and non-screening group at the time of diagnosis and confirm the efficiency of the screening programme.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening Group | Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after FOBT). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Král | Institution for Clinical and Experimental Medicine | +420605273008 | jan.kral@centrum.cz |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER |
| Medic Kral Ltd. | UNKNOWN |
| Chomutov Hospital | UNKNOWN |
| Tomas Bata Hospital, Czech Republic | OTHER |
| Military University Hospital, Prague | OTHER |
| Frýdek-MÃstek Hospital | UNKNOWN |
| The University Hospital Plzeň | UNKNOWN |
| Vitkovice Hospital | OTHER |
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| Colorectal Cancer Resection Margins |
Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group.
|
| after surgery was performed |
| Colorectal Cancer Metastasis | Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Colorectal Cancer Grade | Differences between colorectal cancer grade in screening vs. non-screening group.
Grades 1,2 were considered to have connection with lower stage | Posted | Count of Participants | Participants | 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.
| Posted | Count of Participants | Participants | after surgery was performed |
|
|
|
| Secondary | Colorectal Cancer Metastasis | Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.
| Posted | Count of Participants | Participants | at time of diagnosis |
|
|
|
| Secondary | Colorectal Cancer Surgery | Median time between diagnosis and surgery. | Posted | Median | 95% Confidence Interval | Number of day betw. diagnosis and surg. | 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. | Posted | Count of Participants | Participants | during treatment plan setting |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-screening Group | Symptomatic CRC was defined as carcinoma detected by CT, MR or sonography and then verified by colonoscopy. | 0 | 0 | 0 | 0 |
Results can be published exclusively by the main investigator or after main investigator approval.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065308 | Morphological and Microscopic Findings |