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Screening for Colorectal Cancer in Average and High Risk Population

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ClinicalTrials.gov Identifier: NCT04017845
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Research & Development Directorate, Ministry of Higher Education, Iraq
Al-Kindy College of Medicine
Information provided by (Responsible Party):
Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine

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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Colorectal Cancer Adenomatous Polyp of Colon 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 Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 537 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Colorectal Cancer in Average and High Risk Iraqi Population: A Pilot Study
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Household-Open Invitation (HOI)
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
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
Other Names:
  • Fecal Immunochemical Test (FIT)
  • Fecal occult blood tests (FOBT)
  • FOB Gold/SENTiFOB (Sentinel Diagnostics SpA, Milan, Italy)

Procedure: Precolonoscopy cleansing regimen
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.
Other Name: PICOPREP- Adjuvant Bisacodyl Regimen

Procedure: Conventional Colonoscopy
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.
Other Name: Optical Colonoscopy

Diagnostic Test: Histopathological examinations of screen-detected lesions
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.
Other Name: Histological examinations of Lesion Biopsies and Resections

Drug: Tribenoside 400 mg + lidocaine 40 mg suppositories
Treatment of hemorrhoids was initiated with tribenoside 400 mg + lidocaine 40 mg suppositories, once daily for up to 2 weeks.
Other Name: PROCTO-GLYVENOL

Drug: Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment
Treatment of anal fissure was initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment applied every 12 hours, for up to six weeks.
Other Name: Topical calcium channel blockers/nitrates

Active Comparator: Recommendation By Physician (RBP)
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
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
Other Names:
  • Fecal Immunochemical Test (FIT)
  • Fecal occult blood tests (FOBT)
  • FOB Gold/SENTiFOB (Sentinel Diagnostics SpA, Milan, Italy)

Procedure: Precolonoscopy cleansing regimen
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.
Other Name: PICOPREP- Adjuvant Bisacodyl Regimen

Procedure: Conventional Colonoscopy
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.
Other Name: Optical Colonoscopy

Diagnostic Test: Histopathological examinations of screen-detected lesions
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.
Other Name: Histological examinations of Lesion Biopsies and Resections

Drug: Tribenoside 400 mg + lidocaine 40 mg suppositories
Treatment of hemorrhoids was initiated with tribenoside 400 mg + lidocaine 40 mg suppositories, once daily for up to 2 weeks.
Other Name: PROCTO-GLYVENOL

Drug: Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment
Treatment of anal fissure was initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment applied every 12 hours, for up to six weeks.
Other Name: Topical calcium channel blockers/nitrates




Primary Outcome Measures :
  1. prevalence of causes accounting for population disagreement to participate in screening. programme. [ Time Frame: Documented on one occasion, during invitation interview as an act on disagreement to participate in the 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.

  2. Prevalence of CRC risk factors and risk stratification in target population. [ Time Frame: Documented on one occasion, during invitation interview, as an act on agreement to participate in the screening programme. ]
    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).

  3. Performance Indicators of Fecal Immunochemical Test (FIT) [ Time Frame: Documented on one occasion, immediately after completion of FIT testing. ]
    the performance of Fecal Immunochemical Test (FIT) during the screening process was assessed in terms of participation rate,completion rate and positivity rate.

  4. Performance Indicators of Colonoscopic Examination [ Time Frame: Documented on one occasion, immediately after completion of colonoscopy 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.


Other Outcome Measures:
  1. Quality assurance of Fecal Immunochemical Test (FIT): short questionnaire [ Time Frame: Documented on one occasion, immediately after completion of FIT testing. ]

    Quality assurance of the Fecal Immunochemical Test (FIT) was assessed by a short questionnaire related to the sampling and testing process including:

    1. the ease of use of FOB Gold Tube NG fecal collection device.
    2. the suitability of the post-sampling storage and transportation processes.
    3. the number of unacceptable specimens due to sample error or delay.
    4. the number of received samples appropriately analyzed within the time specified in study protocol.

  2. Quality assurance of precolonoscopy cleansing regimen: Ottawa Bowel Preparation Scale (OBPS) [ Time Frame: Documented on one occasion, immediately after completion of colonoscopy examination. ]

    The precolonoscopy cleansing regimen was assessed according to the quality of bowel preparation for colonoscopies using the total Ottawa Bowel Preparation Scale (OBPS).The scale individually assesses three parts of the colon: (1) the right colon, (2) the middle colon and (3) the rectosigmoid colon. Subscores of 0 to 4 were used for each section of the colon, along with a fourth separate subscore of 0 to 2 for overall fluid .These four individual subscores are added, and the total score of between 0 and 14 provides an assessment of bowel preparation quality, which is judged as:

    1. An excellent bowel preparation has a total score of 0 to 1.
    2. A good bowel preparation has a score of 2 to 4.
    3. A fair bowel preparation has a score of 5 to 7.
    4. A poor bowel preparation has a score of 8 to 10.
    5. An inadequate bowel preparation has a score of 11 to 14.

  3. Safety and tolerance of precolonoscopy cleansing regimen: short questionnaire [ Time Frame: Documented on one occasion, immediately after completion of colonoscopy examination. ]

    Safety and tolerance of precolonoscopy cleansing regimen was assessed by a short questionnaire including:

    1. frequency and severity of associated symptoms.( nausea, vomiting, chest pain, abdominal cramps and abdominal distension).
    2. frequency of related complications ( electrolytes imbalance, dehydration, brief loss of consciousness, convulsions, syncope and ischemic colitis).
    3. ability to complete bowel preparation.
    4. willingness to repeat the same bowel preparation.

  4. Quality assurance of colonoscopic examination: rates of ceacal intubation and the lesions detection rate [ Time Frame: Documented on one occasion, immediately after completion of colonoscopy examination. ]
    The quality of colonoscopic examination was assessed according to the rates of ceacal intubation and the lesions detection rate.

  5. safety and tolerance of colonoscopy. [ Time Frame: Documented on one occasion, immediately after completion of colonoscopy examination. ]

    Safety and tolerance of colonoscopy examination was assessed by a short questionnaire including:

    1. frequency and severity of associated discomfort and or abdominal pain.
    2. frequency of related complications ( cardio-respiratory event, perforation, bleeding and infection).
    3. ability to complete colonoscopy examination.
    4. willingness to repeat the same colonoscopy examination.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017845


Locations
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Iraq
Lewai S Abdulaziz
Baghdad, Iraq, 10045
Sponsors and Collaborators
Lewai Sharki Abdulaziz, MSc PhD
Research & Development Directorate, Ministry of Higher Education, Iraq
Al-Kindy College of Medicine
Investigators
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Study Chair: Lewai S Abdulaziz, MSc PhD Al-Kindy college of Medicine, University of Baghdad
Principal Investigator: 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

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Responsible Party: Lewai Sharki Abdulaziz, MSc PhD, Assistant Professor, Al-Kindy College of Medicine
ClinicalTrials.gov Identifier: NCT04017845     History of Changes
Other Study ID Numbers: 3Al-KindyCM
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lewai Sharki Abdulaziz, MSc PhD, Al-Kindy College of Medicine:
Colorectal cancer
Screening
Fecal Immunochemical Test
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenomatous Polyps
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Tribenoside
Lidocaine
Diltiazem
Nitroglycerin
Bisacodyl
Picosulfate sodium
Calcium Channel Blockers
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs