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

Colorectal Cancer Clinical Trial

— CRCScreen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875793
• Other study ID #: TU-077/019/012
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: July 10, 2022

Study information

• Verified date: December 2022
• Source: University of Tabuk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colorectal Cancer
• Colorectal Neoplasms
• Occult Bleeding

Intervention

Diagnostic Test:
• Stool 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.

Locations

Country	Name	City	State
Saudi Arabia	Public Primary Health Care Centers in the Tabuk City	Tabuk

Sponsors (5)

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

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 - 12 months
Primary	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	1 - 12 months
Secondary	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	1 - 12 months