Colorectal NeoplasmsCRCScreenNCT04875793
Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial
A study testing Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups in people with Colorectal Neoplasms and Colorectal Cancer, run by University of Tabuk at 1 site in Saudi Arabia.
Trial summary
The global burden of colorectal cancer (CRC) incidence among young age groups is rising and overwhelming. This new trend of young-onset CRC incidence is evident in western countries. Unfortunately, Asian countries have shown the same epidemic shift in the past few years. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer, Colonic Polyp
- What is being tested?
- Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jun 2021to 10 Jul 2022
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants will be individuals with an average risk of colorectal cancer, age: 40 years and above of both genders
Who cannot join
- Individuals age less than 40 years or severely ill individuals
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Public Primary Health Care Centers in the Tabuk City
Tabuk, 71491
About this study
Official title: Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial
The global burden of colorectal cancer (CRC) incidence among young age groups is rising and overwhelming. This new trend of young-onset CRC incidence is evident in western countries. Unfortunately, Asian countries have shown the same epidemic shift in the past few years. As a consequence, this situation might necessitate revisiting the current screening program in this region.
Saudi Arabia has a two-fold increase in CRC incidence among young age groups in the last 18 years (9.6/100000 for male versus 9.3/100000 for female). This rising incidence ascribed to the lack of a screening program and suggested lowering CRC screening to 40.
The low awareness about risk factors, signs, and symptoms of the disease causes late presentation of CRC cases. Therefore, most presenting cases are associated with a poor prognosis and short survival. Educational and screening programs are, by no means, considered valuable and essential as CRC tends to affect younger age groups.
Read the detailed description
CRC is cancer that starts in the innermost lining mucosa of the colon or rectum. According to the global cancer Observatory (GCO) 2018, CRC incidence is the third (10.2%) globally, after lung and breast cancers (11.6%). In Saudi Arabia, 2010 report, the incidence was 10.4/100,000 that slightly higher in male groups. Unfortunately, the incidence among young age groups is more than that in countries with high incidence.
Most of the CRCs initially found as small benign growth or projections known as polyps inside the lumen of colorectal space. A polyp is precancerous if it is >1 cm or the presence of more than two polyps, or if dysplasia present after the polyp removal. There are two main types of polyps: precancerous and hyperplastic polyps or inflammatory polyps, which are not precancerous. The early resection will prevent future cancer development and total cure.
Different lifestyle factors that could increase CRC's risk include lack of regular physical exercise, a diet low in fruit and vegetables, a low-fibre and high-fat diet, diary intake during adolescence, overweight and obesity, alcohol consumption and tobacco use. Adherence to CRC screening is essential to limit CRC cancer incidence and improve population health; and then, health providers need to understand the stages of the disease to recommend effective screening strategies.
- Being tested
- Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkupsDiagnostic test
Also called Facilitated appointment to receive a digestive health check and a comprehensive medical checkups
participants will be drawn from all public government institutions inside Tabuk city(outreach). The institution head will be requested to give wellness cards to the eligible employee to receive comprehensive testing for free in addition to CRC test in selected public health centres.
| Study group | Role | What they receive |
|---|---|---|
| List of health centers that randomly allocated to receive the intervention | Experimental | The intervention is the integrated system which is composed of psychologist, endoscopy physician, family physician, community outreach, and audiovisuals in the waiting area. In addition to text messages of information, education and communication (IEC) delivered to the participants at the outreach, and education campaigns to mobilize individuals going for screening. Receives: Diagnostic Test: Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups |
| List of health centers that randomly allocated to receive routine care | No intervention | The comparators will be individuals with an average risk of colorectal cancer of both genders attending the randomly selected health centres |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of individuals who screened positive in the intervention group vs. control group.
The comparison of rate positive screening between the intervention and routine care
Measured: 1 - 12 months
The enrollment rate of individuals who underwent CRC screening in the intervention group vs. control group
The comparison of the enrollment rate between the intervention and routine care
Measured: 1 - 12 months
Secondary outcomes (1)
The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.
Per cent of enrollment in colonoscopy appointment and future follow-up
Measured: 1 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start10 Jun 2021
- Primary completion10 Jun 2022
- Study completion10 Jul 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- List of health centres that randomly allocated to receive the intervention
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tabuk
- Sponsor type
- University, hospital or other
- Collaborators
- Ein Al-Hayat Medical Complex, The Charitable Society for Health Care in Tabuk, Ministry of Health, Saudi Arabia, Vision Health Consultancy Firm, Sudan
- Responsible party
- Principal investigator, Fakhralddin Abbas Mohammed Elfakki, University of Tabuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875793
- Sponsor's protocol ID
- TU-077/019/012
- Acronym
- CRCScreen
- Status last verified
- Dec 2022
- First submitted
- 1 May 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT04875793
- Acronym / sponsor ID
- CRCScreen / TU-077/019/012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of TabukUniversity, hospital or other
- Collaborators
- Ein Al-Hayat Medical Complex, The Charitable Society for Health Care in Tabuk, Ministry of Health, Saudi Arabia, Vision Health Consultancy Firm, Sudan
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 6 May 2021 (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.
The global burden of colorectal cancer (CRC) incidence among young age groups is rising and overwhelming. This new trend of young-onset CRC incidence is evident in western countries. Unfortunately, Asian countries have shown the same epidemic shift in the past few years. As a consequence, this situation might necessitate revisiting the current screening program in this region.
Saudi Arabia has a two-fold increase in CRC incidence among young age groups in the last 18 years (9.6/100000 for male versus 9.3/100000 for female). This rising incidence ascribed to the lack of a screening program and suggested lowering CRC screening to 40.
The low awareness about risk factors, signs, and symptoms of the disease causes late presentation of CRC cases. Therefore, most presenting cases are associated with a poor prognosis and short survival. Educational and screening programs are, by no means, considered valuable and essential as CRC tends to affect younger age groups.
Detailed description
CRC is cancer that starts in the innermost lining mucosa of the colon or rectum. According to the global cancer Observatory (GCO) 2018, CRC incidence is the third (10.2%) globally, after lung and breast cancers (11.6%). In Saudi Arabia, 2010 report, the incidence was 10.4/100,000 that slightly higher in male groups. Unfortunately, the incidence among young age groups is more than that in countries with high incidence.
Most of the CRCs initially found as small benign growth or projections known as polyps inside the lumen of colorectal space. A polyp is precancerous if it is >1 cm or the presence of more than two polyps, or if dysplasia present after the polyp removal. There are two main types of polyps: precancerous and hyperplastic polyps or inflammatory polyps, which are not precancerous. The early resection will prevent future cancer development and total cure.
Different lifestyle factors that could increase CRC's risk include lack of regular physical exercise, a diet low in fruit and vegetables, a low-fibre and high-fat diet, diary intake during adolescence, overweight and obesity, alcohol consumption and tobacco use. Adherence to CRC screening is essential to limit CRC cancer incidence and improve population health; and then, health providers need to understand the stages of the disease to recommend effective screening strategies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- List of health centres that randomly allocated to receive the intervention
| Arm | Type | Receives |
|---|---|---|
| List of health centers that randomly allocated to receive the intervention | Experimental | Diagnostic Test: Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkupsThe intervention is the integrated system which is composed of psychologist, endoscopy physician, family physician, community outreach, and audiovisuals in the waiting area. In addition to text messages of information, education and communication (IEC) delivered to the participants at the outreach, and education campaigns to mobilize individuals going for screening. |
| List of health centers that randomly allocated to receive routine care | No intervention | –The comparators will be individuals with an average risk of colorectal cancer of both genders attending the randomly selected health centres |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants will be individuals with an average risk of colorectal cancer, age: 40 years and above of both genders
Key exclusion criteria (1 listed)
- Individuals age less than 40 years or severely ill individuals
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 |
|---|---|---|
| Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkupsAlso: Facilitated appointment to receive a digestive health check and a comprehensive medical checkupsparticipants will be drawn from all public government institutions inside Tabuk city(outreach). The institution head will be requested to give wellness cards to the eligible employee to receive comprehensive testing for free in addition to CRC test in selected public health centres. | Diagnostic test | List of health centers that randomly allocated to receive the intervention |
Primary outcome
The percentage of individuals who screened positive in the intervention group vs. control group.
Time frame: 1 - 12 months
The comparison of rate positive screening between the intervention and routine care
The enrollment rate of individuals who underwent CRC screening in the intervention group vs. control group
Time frame: 1 - 12 months
The comparison of the enrollment rate between the intervention and routine care
1 secondary outcome
The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.
Time frame: 1 - 12 months
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 7 Dec 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups in people with Colorectal Neoplasms and Colorectal Cancer, run by University of Tabuk at 1 site in Saudi Arabia.
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 1 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 7 Dec 2022. 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 Saudi Arabia. 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?
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?
The percentage of individuals who screened positive in the intervention group vs. control group. (time frame: 1 - 12 months). The study lists 2 primary outcomes in all. 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 7 Dec 2022.