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Completed

NCT Number: NCT04875793

Effectiveness of an Integrated Colorectal Cancer Screening 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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colonic Polyp Colonic Polyps Colorectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Occult Bleeding Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Primary Health Care Centers in the Tabuk City

Tabuk, 71491, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups

Diagnostic Test

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.

Other names: Facilitated appointment to receive a digestive health check and a comprehensive medical checkups

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    Per cent of enrollment in colonoscopy appointment and future follow-up

Sponsors and collaborators

Lead sponsor

University of Tabuk

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CRCScreen

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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