Colorectal CancerCRCNCT02727894
Colorectal Cancer: Screening vs. Non-Screening
An observational study of Colorectal Cancer and Screening, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Screening
- How many people
- 276 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2013to Jan 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinics, university hospitals, private practices
Who may be able to join
- newly diagnosed colorectal cancer
Who cannot join
- unsigned informed consent
- mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes
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.
Read the 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
- Conditions
- Colorectal Cancer, Screening
- Keywords
- Screening, pTNM, Metastasis, Chemotherapy, Resection Margins, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at time of diagnosis
Secondary outcomes (5)
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
Measured: after surgery was performed
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)
Measured: after surgery was performed
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
Measured: at time of diagnosis
Colorectal Cancer Surgery
Median time between diagnosis and surgery.
Measured: 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.
Measured: during treatment plan setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- 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
- Responsible party
- Principal investigator, Jan Král, MD, Institute for Clinical and Experimental Medicine
- Investigators
- Jan Král, M.D., Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727894
- Sponsor's protocol ID
- 00023001-2015
- Acronym
- CRC
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2016
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02727894
- Acronym / sponsor ID
- CRC / 00023001-2015
- Conditions
- Colorectal Cancer, Screening
- Keywords
- Screening, pTNM, Metastasis, Chemotherapy, Resection Margins, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- 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
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinics, university hospitals, private practices
Key inclusion criteria (1 listed)
- newly diagnosed colorectal cancer
Key exclusion criteria (2 listed)
- unsigned informed consent
- mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Colorectal Cancer Grade
Time frame: after surgery was performed
Colorectal Cancer Resection Margins
Time frame: after surgery was performed
Colorectal Cancer Metastasis
Time frame: at time of diagnosis
Colorectal Cancer Surgery
Time frame: time between diagnosis and surgery, measured after surgery was performed
Colorectal Cancer and Palliative Therapy
Time frame: during treatment plan setting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Král, M.D. principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Screening, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal Cancer Stage (pTNM) (time frame: at time of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.