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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201905806116817 Date of Registration: 06/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cervical Cancer Screening Study
Official scientific title Clinical studies and in-depth interviews for portable, low-cost, and speculum-free cervical cancer screening in Ghana.
Brief summary describing the background and objectives of the trial (i) Background: Early screening and treatment of pre-cancerous lesions is a cost-effective strategy for reducing preventable mortality due to cervical cancer; however, coverage of cervical cancer screening programs remains inadequate in resource-limited settings, resulting in cancer progression and high mortality for women in such regions. Limitations to widespread coverage include expensive screening tools, loss of women to follow up, and fear of the speculum exam. To overcome some of the limitations with cervical cancer screening, we have developed the Callascope, a low-cost, speculum-free cervix imaging tool that can replace both the speculum and colposcope for more cost-effective and comfortable cervical cancer screening. The Callascope works with a mobile and computer-based application that can conveniently capture and store images of the cervix using a mobile phone, tablet or computer. (ii) General Aim: This work seeks to pilot the Callascope in Ghana for widespread cervical cancer screening to determine endpoints of feasibility for clinical and community use, as well as patient and health provider acceptance. (iii) Methodology: There will be three main studies performed. (1) Clinical studies in which a physician uses the Callascope with patients. Objectives: a) Feasibility of visualizing the cervix, b) Cervix area visualized compared to standard-of-care speculum, c) Diagnostic concordance compared to standard of care, d) Ease of use, e) Patient acceptability; (2) A volunteer study in which healthy volunteers use the Callascope for self-cervix imaging. Objectives: a) Feasibility of visualizing the cervix, b) Ease of use, c) Acceptability; and (3) in-depth interviews Objectives: Understand Knowledge and beliefs around reproductive health and cervical cancer, perceptions towards speculum and Callascope. Secondary objectives of the stud include assessing safety (based on participant/ physician reports).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Cervical Cancer
Purpose of the trial Early detection /Screening
Anticipated trial start date 23/04/2019
Actual trial start date 29/04/2019
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 68
Recruitment status Completed
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
Control Group Standard of care colposcopy We are testing an imaging device. Dosage is not applicable. Standard, imaging of the cervix is determined by physician. 30 minutes none 50 Active-Treatment of Control Group
Experimental Group Use of Callascope to take an image of the cervix before standard ofcare procedure not applicable. 2-5 images of the cervix will be taken. The Callascope is similar to a mobile phone 15 mintues Pen-sized camera used to capture an image of the cervix. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria • Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer. • Age 21 and greater • Patients of all ethnicities will be included. • Ability to understand and the willingness to sign a written informed consent document. • Fluent in English, Ga or Asante Twi. Exclusion criteria: • Subjects under 21. • Pregnant women in their 2nd and 3rd trimesters • Women who are on their periods Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 Year(s) Female
Inclusion criteria • Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer. • Age 21 and greater • Patients of all ethnicities will be included. • Ability to understand and the willingness to sign a written informed consent document. • Fluent in English, Ga or Asante Twi. Exclusion criteria: • Subjects under 21. • Pregnant women in their 2nd and 3rd trimesters • Women who are on their periods Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 65 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 20/11/2018 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P. O. Box MB 190 Accra 00233 Ghana
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 08/11/2018 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
P. O. Box KB 77 Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feasibility of visualizing cervix During procedure
Primary Outcome Cervix visualization of Callascope compared to speculum After Procedure
Primary Outcome Concordance of diagnosis using Callascope image compared to standard of care Following completion of study
Primary Outcome Ease of use After procedure
Primary Outcome Patient acceptability After procedure
Primary Outcome Understand Knowledge and beliefs around reproductive health and cervical cancer, perceptions towards speculum and Callascope After study completion
Secondary Outcome Safety One month after study completion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Guggisberg Ave, Korlebu Accra Ghana
Greater Accra Regional Hospital Castle Rd Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Duke Global Health Institute Doctoral Dissertation Grant 310 Trent Dr, Durham, NC 27710, USA Accra 27710 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mercy Asiedu 610 S. Lasalle Street, Apartment H Durham 27705 United States of America Individual
COLLABORATORS
Name Street address City Postal code Country
Emmanuel Srofenyoh Castle Rd Accra 00233 Ghana
Ali Samba Guggisberg Ave Accra Ghana
Kwaku Asah Opoku Guggisberg Ave Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Srofenyoh emmanuelsrofenyoh@gmail.com +233261927679 Castle Road
City Postal code Country Position/Affiliation
Accra Ghana Director of Greater Accra Regional Hospital
Role Name Email Phone Street address
Principal Investigator Ali Samba abmasa@yahoo.com +233267647367 Guggisberhg Ave
City Postal code Country Position/Affiliation
Accra Ghana Medical Director of Korle Bu Teaching Hospital
Role Name Email Phone Street address
Principal Investigator Nimmi Ramanujam nimmi.ramanujam@duke.edu +19194758358 101 Science Drive
City Postal code Country Position/Affiliation
Durham 27708 United States of America Professor of Biomedical Engineering and Global Health
Role Name Email Phone Street address
Scientific Enquiries Mercy Asiedu mercy.asiedu@duke.edu +233246649599 610 S. Lasalle Street
City Postal code Country Position/Affiliation
Durham 27705 United States of America Graduate Research Assistant and primary researcher on the study
Role Name Email Phone Street address
Public Enquiries Mercy Asiedu mercy.asiedu@duke.edu +233246649599 610 S. Lasalle street, temporarily relocated to Ghana for the study
City Postal code Country Position/Affiliation
Durham 27705 United States of America Graduate Research Assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified participant images and survey responses Statistical Analysis Plan,Study Protocol within a year of study completion Open access
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