Screening for Colorectal Cancer in Average and High Risk Population

NCT04017845 | Completed Early Phase 1

• 1 other identifier: 3Al-KindyCM
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 1

Brief Summary

The existing evidence from epidemiological studies and randomized controlled trials has consistently assures the cost effectiveness and the influential role of screening in reducing incidence rates and deaths caused by Colorectal Cancer (CRC). Population based organized screening programmes, which should be considered an obligation that is not to be postponed, require valuable information that can be reliably extrapolated from well-designed pilot study conducted prior to programme implementation. The main objectives of the current pilot CRC screening project, named after "Al-Kindy College of Medicine", was to evaluate and explore the specific aspects of the intended population-based organized CRC screening programme, including: barriers affecting adherence to the programme, performance indicators of the proposed screening programme, the target population in which CRC screening is a legitimate healthcare priority, quality assurance of screening tests and colonoscopy services, and to propose an algorithm that will provide a clinically and logistically acceptable positivity rate.

Conditions

Colorectal Neoplasms; Colorectal Cancer; Adenomatous Polyp of Colon

Keywords

Colorectal cancer; Screening; Fecal Immunochemical Test

Outcome Measures

Primary Outcomes (4)

• prevalence of causes accounting for population disagreement to participate in screening. programme.

  Eligible screenees who do not have the willingness to participate were asked to identify their disagreement cause(s) from the list included in the invitation letter and reported as: 1. I don't have the will or time to be enrolled. 2. My residence is far off the program center. 3. I am afraid the program will unveil the presence of the disease. 4. I cannot accept and tolerate the tests included in the program. 5. I am not fully persuaded about the program achievability. 6. Infeasibility of freely provided medical services.

  Documented on one occasion, during invitation interview as an act on disagreement to participate in the screening programme.

• Prevalence of CRC risk factors and risk stratification in target population.

  individuals of the target population were divided into three risk groups based on survey and medical record data: high-risk (history of polyps, and/or personal/family history of CRC, increased-risk (diabetes, obesity, and/or former or current smoking status), and average-risk (45 or older with no other risk factor).

  Documented on one occasion, during invitation interview, as an act on agreement to participate in the screening programme.

• Performance Indicators of Fecal Immunochemical Test (FIT)

  the performance of Fecal Immunochemical Test (FIT) during the screening process was assessed in terms of participation rate,completion rate and positivity rate.

  Documented on one occasion, immediately after completion of FIT testing.

• Performance Indicators of Colonoscopic Examination

  the performance of follow up colonoscopy during the screening process was assessed in terms of referral rate, compliance rate, completion rate and lesion detection rate.

  Documented on one occasion, immediately after completion of colonoscopy examination.

Other Outcomes (5)

• Quality assurance of Fecal Immunochemical Test (FIT): short questionnaire

  Documented on one occasion, immediately after completion of FIT testing.

• Quality assurance of precolonoscopy cleansing regimen: Ottawa Bowel Preparation Scale (OBPS)

  Documented on one occasion, immediately after completion of colonoscopy examination.

• Safety and tolerance of precolonoscopy cleansing regimen: short questionnaire

  Documented on one occasion, immediately after completion of colonoscopy examination.

Study Arms (2)

Household-Open Invitation (HOI)

ACTIVE COMPARATOR

Precolonoscopy cleansing regimen and referral to conventional colonoscopy is based on Positive FIT (level ≥75ng/ml) in any of the two collected samples. Histopathological examinations of screen-detected lesions are reported and lesion with the worst prognosis is indicated as the final colonoscopic outcome used for evaluation purposes. Screenees with intermediate and high risk polyp were referred to a follow-up surveillance programme.Treatments were initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment for anal fissure, and tribenoside 400 mg + lidocaine 40 mg suppositories for hemorrhoids. Positive FIT results in participants who were identified with no adenomas, advance adenomas, or adenocarcinomas are considered False-positive FIT (FP-FIT) results.

Diagnostic Test: FIT; Procedure: Precolonoscopy cleansing regimen; Procedure: Conventional Colonoscopy; Diagnostic Test: Histopathological examinations of screen-detected lesions; Drug: Tribenoside 400 mg + lidocaine 40 mg suppositories; Drug: Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment

Recommendation By Physician (RBP)

ACTIVE COMPARATOR

Precolonoscopy cleansing regimen and referral to conventional colonoscopy is based on Positive FIT (level ≥75ng/ml) in any of the two collected samples. Histopathological examinations of screen-detected lesions are reported and lesion with the worst prognosis is indicated as the final colonoscopic outcome used for evaluation purposes. Screenees with intermediate and high risk polyp were referred to a follow-up surveillance programme.Treatments were initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment for anal fissure, and tribenoside 400 mg + lidocaine 40 mg suppositories for hemorrhoids. Positive FIT results in participants who were identified with no adenomas, advance adenomas, or adenocarcinomas are considered False-positive FIT (FP-FIT) results.

Diagnostic Test: FIT; Procedure: Precolonoscopy cleansing regimen; Procedure: Conventional Colonoscopy; Diagnostic Test: Histopathological examinations of screen-detected lesions; Drug: Tribenoside 400 mg + lidocaine 40 mg suppositories; Drug: Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment

Interventions

FIT DIAGNOSTIC_TEST

Screenees were supplied with two fecal collection devices and asked to collect two specimens from two consecutive Different Bowel Movement Samples (DBMS) or, in case of infrequent bowel movements, from the Same Bowel Movement Sample (SBMS).Instruction stressed that after collection the device must be stored in refrigerator and transported in an iced pack within no more than 48h from sampling. After checking for sampling appropriateness, the received samples were analyzed by the FOB Gold/SENTiFOB method (Sentinel Diagnostics SpA, Milan, Italy), according to the previously validated procedural platform

Also known as: Fecal Immunochemical Test (FIT), Fecal occult blood tests (FOBT), FOB Gold/SENTiFOB (Sentinel Diagnostics SpA, Milan, Italy)

Household-Open Invitation (HOI); Recommendation By Physician (RBP)

Precolonoscopy cleansing regimen PROCEDURE

Laxative stimulant two days prior to the cleansing regimen involves the intake of one 10 mg tablet of bisacodyl (Dulcolax, Sanofi,UK) at 18:00 for two consecutive nights.The evening before colonoscopy cleansing started with 2 doses (at 16:00 and 20:00) of one sachet Sodium picosulphate preparations (PICOPREP, Ferring Pharmaceutical Co., Ltd., Zhongshan, China), dissolved in150 mL of cold water, followed with five 240 mL portions of clear liquids within 3 h. The third dose is taken in the morning about 5 h prior to colonoscopy, followed with at least three 240 mL portions of clear liquids no later than 2 h before colonoscopy.

Also known as: PICOPREP- Adjuvant Bisacodyl Regimen

Household-Open Invitation (HOI); Recommendation By Physician (RBP)

Conventional Colonoscopy PROCEDURE

With the colonoscopists completely blinded regarding the FIT results, conventional colonoscopy examinations were conducted in the Endoscopy Unit of Al-Kindy Polyclinic. According to the five levels of competency proposed by the European guidelines, this unit is assigned as level 2, with the possibility of removing polypoid and sessile lesions \<25 mm, providing there is good access. For flat lesions, larger sessile and polypoid lesions, and smaller lesions with more difficult access, the lesions were documented appropriately with the patients referred to higher competent units in order to be safely and expertly removed.

Also known as: Optical Colonoscopy

Household-Open Invitation (HOI); Recommendation By Physician (RBP)

Histopathological examinations of screen-detected lesions DIAGNOSTIC_TEST

Adenomas were classified according to the modified revised Vienna classification for the European Guidelines. Advanced adenoma was defined as the presence of one of the following features: \>10 mm diameter, tubulovillous or villous structure, and high-grade neoplasia. Polypoid adenocarcinomas were reported according to the TNM classification, while colorectal cancer associated with flat and/or depressed lesions were reported as non-polypoid lesions, and further classified by the Paris classification. Pathologic results of hyperplastic polyps, sessile serrated lesions or post inflammatory polyps were considered normal findings.

Also known as: Histological examinations of Lesion Biopsies and Resections

Household-Open Invitation (HOI); Recommendation By Physician (RBP)

Tribenoside 400 mg + lidocaine 40 mg suppositories DRUG

Treatment of hemorrhoids was initiated with tribenoside 400 mg + lidocaine 40 mg suppositories, once daily for up to 2 weeks.

Also known as: PROCTO-GLYVENOL

Household-Open Invitation (HOI); Recommendation By Physician (RBP)

Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment DRUG

Treatment of anal fissure was initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment applied every 12 hours, for up to six weeks.

Also known as: Topical calcium channel blockers/nitrates

Household-Open Invitation (HOI); Recommendation By Physician (RBP)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• residents of Baghdad city
• being ≥45 years of age with stop age of 80 years.

You may not qualify if:

• history of inflammatory bowel disease (IBD).
• colonoscopy (CS)/flexible sigmoidoscopy (FS)/ double contrast barium enema (DCBE) performed within the last year.
• persistent altered bowel habits.
• chronic abdominal pain.
• visible bleeding per rectum.
• long term use of anticoagulant.

Sponsors & Collaborators

• Lewai Sharki Abdulaziz, MSc PhD: lead
• Research & Development Directorate, Ministry of Higher Education, Iraq: collaborator
• Al-Kindy College of Medicine: collaborator

Study Sites (1)

Lewai S Abdulaziz

Baghdad, 10045, Iraq

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tribenoside; Lidocaine; Suppositories; tribenoside (combination); Diltiazem; Calcium Channel Blockers; Nitrates

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds

Study Officials

• Lewai S Abdulaziz, MSc PhD

  Al-Kindy college of Medicine, University of Baghdad

  STUDY CHAIR

• Faris A Khazaal, FRCP

  Al-Kindy college of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

• Riyadh M Hasan, CABS

  Al-Kindy college of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

• Mohammed A Al-Kurtas, FICMS.Path

  Al-Kindy college of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 12, 2019
• Study Start: April 1, 2015
• Primary Completion: May 30, 2017
• Study Completion: October 30, 2017
• Last Updated: September 4, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)