Clinical trial NCT04875793: Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial
Official title: Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colorectal Cancer
Colonic Polyp
Occult Bleeding
Lead sponsor: University of Tabuk
Sponsor class: OTHER
Collaborators: name: Ein Al-Hayat Medical Complex
name: The Charitable Society for Health Care in Tabuk
name: Ministry of Health, Saudi Arabia
name: Vision Health Consultancy Firm, Sudan
First posted: 2021-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: List of health centres that randomly allocated to receive the intervention
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of individuals who screened positive in the intervention group vs. control group.
timeFrame: 1 - 12 months
measure: The enrollment rate of individuals who underwent CRC screening in the intervention group vs. control group
timeFrame: 1 - 12 months
Secondary outcomes:
measure: The percentage of individuals who screened positive and enrolled in colonoscopy for follow-up in the intervention group vs. control group.
timeFrame: 1 - 12 months
Other outcomes:
Locations:
city: Tabuk
country: Saudi Arabia
facility: Public Primary Health Care Centers in the Tabuk City
Study officials:
References: