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.: PACTR202201864472288 Date of Approval: 11/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Breast cancer detection by dog sniffing in Tunisia
Official scientific title Transcutaneous canine breast cancer detection in Tunisia
Brief summary describing the background and objectives of the trial Breast cancer is a public health problem in Tunisia due to its frequency and severity. The late diagnosis of breast cancer in Tunisia seems to be mainly related to a delay in consultation of women who live in "medical deserts" far from health facilities and radiology centers and who therefore have difficulty benefiting from screening mammograms. Studies based on canine odorology have shown promising results. Indeed, specially trained dogs are endowed with an infinitely developed sense of smell and could detect the presence of volatile organic bodies released by the tumor in human body fluids (urine, breath, sweat). These screening tests, simple, accessible, and low-cost, would be the ideal solution to overcome this delay in diagnosis and reduce inequalities in access to screening, with a major collective impact on women's health. Therefore,this study aims to study the validity and reliability of the method of detecting breast cancer in Tunisian women by canine olfaction.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
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 01/11/2021
Actual trial start date
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Odour sampling 6 months The woman will apply the compress on the concerned breast during the night preceding the day of samplings. The compress, once removed, will be placed in specific sterile plastic vial for the study. Vial will be given to the investigating centre during the appointment of percutaneous samples and then sent to the laboratory of the K9 Dog Centre Security and training in Sousse. Upon receipt of the samples at the K9 Dog Centre Security and training in Sousse, the compresses will be packed in jars and then analyzed by the study dogs. Positive marking is characterized by a sitting position of the dog in front of the sample. 100
Control Group odour sampling 6 months Theses patients after informed consent will benefit a screening mammogram. A breast biopsy will be performed if there are any suspicious abnormalities on the mammogram. Only women with no abnormalities on the mammogram and biopsy will be kept in this group , theses patients will benefit of the odour sampling test. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women 18 years and older, with breast cancer confirmed at histology and not operated yet ; Women 18 years and older, operated on breast cancer and with local relapse of the breast tumor ; Biopsy could be performed at least 1 month ago from the intervention; Signature of the informed consent of the study; Patient who underwent a surgery for benign lesion(s) of the concerned breast in less than 4 weeks before the date of inclusion in this study; Patient who had percutaneous breast biopsies of the concerned breast in less than 4 weeks before the date of inclusion in this study; Patient with bleeding breast cancer and/or skin ulceration; Patient with breast implant(s); Patient taking antibiotics one week before inclusion in the study; Patient with a current viral infection (fever); 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 Year(s) Female
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 18/05/2021 the Research Ethics Committee of Farhat Hached Hospital
Ethics Committee Address
Street address City Postal code Country
Ibn Jazzar street Sousse 4031 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To study the validity and reliability of the method of detecting breast cancer in Tunisian women by canine olfaction. 12 months
Secondary Outcome 1. Demonstrate the sensitivity of this method in Tunisian patients in whom the diagnosis of breast cancer has been histologically proven 2. Determining Sensitivity, Specificity, and Predictive Values of this method 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Carcinology Department Farhat Hached Hospital Sousse Avenue Ibn El Jazzar-Sousse- 4000 Sousse 4031 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Cancer Research and Information Association Rue Mohamed Karoui Sousse 4002 Tunisia
Faculty of Medicine of Sousse Avenue Mohamed Karoui, Sousse 4002 Sousse Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cancer Research and Information Association Rue Mohamed Karoui Sousse 4002 Tunisia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
K9 Dog Center Security and training Sousse Sousse 4060 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Fedy Baya bayafedy@gmail.com +21623500357 30 Rue Ezzouhour , Msaken
City Postal code Country Position/Affiliation
Sousse Tunisia Medical resident in Oncology
Role Name Email Phone Street address
Scientific Enquiries Imtinene Belaid belaid_im@hotmail.fr +21622575652 Akouda
City Postal code Country Position/Affiliation
Sousse Tunisia Associate Professor in Medical Oncology
Role Name Email Phone Street address
Public Enquiries Slim Ben Ahmed slim.benahmed1@gmail.com +21698403148 Sousse
City Postal code Country Position/Affiliation
Sousse Tunisia Professor in Medical Oncology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) . For more information or to submit a request, please contact on the following email: Informed Consent Form,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Requests of data will be answered by mail after discussion between the principal investigator and collaborators. Nevertheless, our laboratory encourages open access, stands in favor of removing barriers for those who seek access to data and sees no limitations on how data can be used in order to promote transparency, reproducibility, and more rapid advancement of new knowledge and discovery.
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