Colorectal NeoplasmsNCT05184751
Incidence and Risk Factors of Early Onset Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Hospital Frydek-Mistek.
Trial summary
Early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. The aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single… Read more about this study
- Who is it for?
- Ages 4 to 97 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- colonoscopy
- How many people
- 18,257 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 97 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients who were indicated for colonoscopic examination (all indications) in period january 2012 to the end of june 2021
Inclusion Criteria: all patient who underwent colonoscopic examination clear indication for colonoscopy
Exclusion Criteria: not able to underwent colonoscopy
About this study
Early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. The aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center.
Read the detailed description
The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. The investigators collected the data from all colonoscopic examinations performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021.
- Conditions
- Colorectal Neoplasms
- Being tested
- colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyOther
| Study group | Role | What they receive |
|---|---|---|
| 50 years and over | patients who underwent colonoscopic examination aged 50 years and over Receives: Other: colonoscopy | |
| under 50 years | patients who underwent colonoscopic examination aged under 50 years Receives: Other: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of early onset colorectal neoplasias, risk factors
the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center, the risk of sex and family history of colorectal cancer
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2012
- Primary completion30 Jun 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Retrospective
- Enrolment
- 18,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Frydek-Mistek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Mikoviny Kajzrlikova, MD, PhD, Hospital Frydek-Mistek
- Investigators
- Ivana Mikoviny Kajzrlikova, Principal investigator, Hospital Frydek-Mistek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184751
- Sponsor's protocol ID
- Early onset colorectal cancer
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Early Onset Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05184751
- Acronym / sponsor ID
- Early onset colorectal cancer
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,257 participants (actual)
- Lead sponsor
- Hospital Frydek-MistekUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. The aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center.
Detailed description
The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. The investigators collected the data from all colonoscopic examinations performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 years and over | – | Other: colonoscopypatients who underwent colonoscopic examination aged 50 years and over |
| under 50 years | – | Other: colonoscopypatients who underwent colonoscopic examination aged under 50 years |
Who may qualify
- Ages
- 4 to 97 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients who were indicated for colonoscopic examination (all indications) in period january 2012 to the end of june 2021
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy | Other | 50 years and over, under 50 years |
Primary outcome
incidence of early onset colorectal neoplasias, risk factors
Time frame: 10 years
the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center, the risk of sex and family history of colorectal cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ivana Mikoviny Kajzrlikova principal investigator
Hospital Frydek-Mistek
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Hospital Frydek-Mistek.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of early onset colorectal neoplasias, risk factors (time frame: 10 years). 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 31 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.