Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902735175581 Date of Approval: 11/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Moroccan Colorectal Cancer Screening, Pilot Demonstration Project in Rabat Region
Official scientific title The Moroccan Colorectal Cancer Screening, Pilot Demonstration Project in Rabat Region
Brief summary describing the background and objectives of the trial In Morocco, colorectal cancer is the third most common cancer among men and women. Most of the reported cases of cancers are diagnosed at very advanced stages when curative therapies are less effective. No organized screening program for colorectal cancer has been organized in Morocco, although sporadic, opportunistic screening might occur in urban areas of Morocco. This study aims to evaluate the acceptability, feasibility, organization, implementation, monitoring and evaluation of CRC screening in the general population setting in Morocco by integrating the program within the existing public health services to inform and guide the eventual large-scale scaling up of CRC screening covering the entire country.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Morocolo
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/11/2016
Actual trial start date 01/06/2017
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 01/08/2019
Anticipated target sample size (number of participants) 10000
Actual target sample size (number of participants) 10000
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group iFOBT test one iFOBT test 5 minutes The iFOBT chosen is a highly sensitive, rapid, convenient and odourless sandwich dye immunoassay for the determination of human occult blood in faeces. It uses a combination of monoclonal and polyclonal antibodies to selectively identify hemoglobin (Hb) in test samples with a high degree of sensitivity. In less than 5 minutes elevated levels of Hb as low as 0.2 uG/ml can be detected and positive results for high levels of Hb can be seen within one or two minutes. At the PCU, the nurse will complete an informed consent form and will perform the assay. The test device is removed from its foil pouch. The collection tube is shaken well, and the tip of the cap on the tube is broken open. Two or three drops of the faecal sample is dispensed into the circular sample well, being careful not to overfill the adsorbent pad and drop faecal sample liquid in to the result windows. The results are read within 5 minutes. The test device is discarded after single use. 10000
Control Group No intervention N/A N/A N/A 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All apparently healthy, ambulant men and women aged 50 to 75 years resident in Rabat region with no debilitating mental or physical illness (schizophrenia, manic depressive psychosis, acute and chronic organ failure (like renal failure), hemiplegia and paraplegia, fulminant tuberculosis) and no past history of CRC are eligible to participate in the CRC pilot screening project. Participants aged lower 50 and over 75 years old. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/09/2016 IARC Ethics Committee
Ethics Committee Address
Street address City Postal code Country
150 cours Albert Thomas Lyon 69372 France
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2016 Ethics Committee for Rabat Biomedical Research
Ethics Committee Address
Street address City Postal code Country
Impasse Souissi Rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stage distribution of CRC detected into the program; Detection rates of polyps, advanced adenoma and CRC for 10 000 screened persons; Positive predictive value of iFOBT for CRC and polyps; CRC detected in the programme as a proportion of all CRC during 2017 (programme sensitivity: CRC detected by the programme/total CRC provided by the hospital-based cancer registry). Frequency of bleeding, tearing, perforation and deaths following colonoscopy; Number of unnecessary exploratory surgeries. At the end of the study
Secondary Outcome Reproducibility of iFOBT offered; Percentage of invalid FOBTs and number of repeat tests and sample collections Percentage of persons with positive iFOBT; Percentage of persons with positive iFOBT undergoing colonoscopy (lost to follow-up); Percentage of CRC patients completing prescribed course of treatment; At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Takaddoum Avenue Al Haouz, El Youssoufia Rabat 10000 Morocco
Nahda I Avenue Targa Rabat 10000 Morocco
Hassan Medina Rabat 10000 Morocco
El Melk Avenue el massira yacoub mansour Rabat 10000 Morocco
Massira Avenue Al Massira Rabat 10000 Morocco
Mers Kheir Rural Skhirate Temara 12050 Morocco
Sidi.Y.Z Rural Skhirate Temara 12050 Morocco
Sebbah Rural Skhirate Temara 12050 Morocco
Skhirat Rural Skhirate Temara 12050 Morocco
Menzeh Rural Skhirate Temara 12050 Morocco
National institute of Oncology Sidi Mohamed Ben Abdellah Avenue Allal El Fassi Rabat 10000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Cancer Research Institute CHU Hassan II, Route Sidi Harazem, Rue du Park Shore Fes 30070 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Agency for Research on Cancer 150, Cours Albert Thomas Lyon 69372 France, Metropolitan The specialized cancer agency of the World Health Organization
Secondary Sponsor The Foundation Lalla Salma Cancer prevention and treatment Villa No. 1, Touarga Fouaka, Mechouar Said Rabat 10000 Morocco Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr Partha Basu International Agency for Research on Cancer, 150 cours Albert Thomas Lyon 69372 France
Dr Youssef Chami Khazraji The Lalla Salma Foundation Cancer Prevention and Treatment, Villa No. 1, Touarga Fouaka, Mechouar Said Rabat 10000 Morocco
Dr Latifa Belakhel Epidemiology and Disease Control Department, Ministry of Health, Rabat, Morocco, 71, avenue Ibn Sina Rabat 10090 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laila Amrani l.amrani@ino.ma +212537712455 National Institute of Oncology, Avenue Allal El Fassi
City Postal code Country Position/Affiliation
Rabat 10100 Morocco Head of the gastroenterology ward National Institute of Oncology
Role Name Email Phone Street address
Scientific Enquiries Partha Basu basup@iarc.fr +33472738167 150 cours Albert Thomas
City Postal code Country Position/Affiliation
Lyon 69372 France Medical Officer International Agency for Research on Cancer
Role Name Email Phone Street address
Public Enquiries Youssef Chami Khazraji youssef.chami@flsc.ma +212661614261 Villa No. 1, Touarga Fouaka, Mechouar Said
City Postal code Country Position/Affiliation
Rabat 10000 Morocco Projects Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 26/05/2020 - National Oncology Institute, Avenue Allal El Fassi, Rabat, 10100, Morocco Dr Partha Basu, International Agency for Research on Cancer, 150 cours Albert Thomas, Lyon, 69372, France
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 26/05/2020 - The Foundation Lalla Salma Cancer prevention and treatment, Villa No. 1, Touarga Fouaka, Mechouar Said, Rabat, 10000, Morocco Dr Youssef Chami Khazraji, The Lalla Salma Foundation Cancer Prevention and Treatment, Villa No. 1, Touarga Fouaka, Mechouar Said, Rabat, 10000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 26/05/2020 - Dr Latifa Belakhel, Epidemiology and Disease Control Department, Ministry of Health, Rabat, Morocco, 71, avenue Ibn Sina, Rabat, 10090, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 26/05/2020 Prof. Laila Amrani is the local PI of the project. Principal Investigator, Partha, Basu, Dr., basup@iarc.fr, , +33472738167, 150 cours Albert Thomas, Lyon, 69372, France, Medical Officer International Agency for Research on Cancer Principal Investigator, Laila, Amrani, Prof., l.amrani@ino.ma, l.amrani@um5s.net.ma, +212537712455, National Institute of Oncology, Avenue Allal El Fassi, Rabat, 10100, Morocco, Head of the gastroenterology ward National Institute of Oncology