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Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial

Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04875793
Acronym
CRCScreen
Enrollment
300
Registered
2021-05-06
Start date
2021-06-10
Completion date
2022-07-10
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp, Colorectal Cancer, Colorectal Neoplasms, Occult Bleeding

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTStool for Occult Blood Test and Colonoscopy with 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.

Sponsors

Ein Al-Hayat Medical Complex
CollaboratorUNKNOWN
The Charitable Society for Health Care in Tabuk
CollaboratorUNKNOWN
Ministry of Health, Saudi Arabia
CollaboratorOTHER_GOV
Vision Health Consultancy Firm, Sudan
CollaboratorUNKNOWN
University of Tabuk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

List of health centres that randomly allocated to receive the intervention

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The participants will be individuals with an average risk of colorectal cancer, age: 40 years and above of both genders

Exclusion criteria

* Individuals age less than 40 years or severely ill individuals

Design outcomes

Primary

MeasureTime frameDescription
The percentage of individuals who screened positive in the intervention group vs. control group.1 - 12 monthsThe 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 group1 - 12 monthsThe comparison of the enrollment rate between the intervention and routine care

Secondary

MeasureTime frameDescription
The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.1 - 12 monthsPer cent of enrollment in colonoscopy appointment and future follow-up

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026