Colorectal Cancer, Screening
Conditions
Keywords
Screening, pTNM, Metastasis, Chemotherapy, Resection Margins, Colorectal Cancer
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
Interventions
None listed
Sponsors
Private practice at Hluboká nad Vltavou
Klaudian Hospital Mladá Boleslav
Masaryk Hospital Usti nad Labem
Brno University Hospital
Medic Kral Ltd.
Chomutov Hospital
Tomas Bata Hospital, Czech Republic
Military University Hospital, Prague
Frýdek-Místek Hospital
The University Hospital Plzeň
Vitkovice Hospital
Institute for Clinical and Experimental Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* newly diagnosed colorectal cancer
Exclusion criteria
* unsigned informed consent * mental disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Colorectal 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 stage |
| 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 body |
| Colorectal 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. |
Countries
Czechia
Participant flow
Recruitment details
From March 2013 till September 2015 in 12 centres across the Czech Republic 276 patients were enrolled.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Screening Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after FOBT). | 73 |
| Others Patients with colorectal cancer diagnosed by other diagnostic procedures (diagnostic colonoscopy, CT, magnetic resonance, ultrasonography, urgent surgery, etc.) | 192 |
| Total | 265 |
Baseline characteristics
| Characteristic | Screening | Others | Total |
|---|---|---|---|
| Age, Customized Age (years, median) | 67.5 years | 70 years | 68 years |
| Sex: Female, Male Female | 29 Participants | 77 Participants | 106 Participants |
| Sex: Female, Male Male | 44 Participants | 115 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: at time of diagnosis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Group | Colorectal Cancer Stage (pTNM) | 46 Participants |
| Non-Screening Group | Colorectal Cancer Stage (pTNM) | 85 Participants |
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.
Time frame: during treatment plan setting
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Group | Colorectal Cancer and Palliative Therapy | 2 Participants |
| Non-Screening Group | Colorectal Cancer and Palliative Therapy | 23 Participants |
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
Time frame: after surgery was performed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Group | Colorectal Cancer Grade | 53 Participants |
| Non-Screening Group | Colorectal Cancer Grade | 120 Participants |
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
Time frame: at time of diagnosis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Group | Colorectal Cancer Metastasis | 55 Participants |
| Non-Screening Group | Colorectal Cancer Metastasis | 104 Participants |
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)
Time frame: after surgery was performed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Group | Colorectal Cancer Resection Margins | 48 Participants |
| Non-Screening Group | Colorectal Cancer Resection Margins | 94 Participants |
Secondary
Colorectal Cancer Surgery
Median time between diagnosis and surgery.
Time frame: time between diagnosis and surgery, measured after surgery was performed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Screening Group | Colorectal Cancer Surgery | 30 Number of day betw. diagnosis and surg. |
| Non-Screening Group | Colorectal Cancer Surgery | 21.5 Number of day betw. diagnosis and surg. |