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.: PACTR202005672126095 Date of Approval: 14/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined transvaginal sonoelastography and abdominal ultrasound versus Magnetic resonance imaging in diagnosis of cancer cervix: RCT
Official scientific title Combined transvaginal sonoelastography and abdominal ultrasound versus magnetic resonance imaging in diagnosis of cancer cervix: randomized controlled trial
Brief summary describing the background and objectives of the trial To compare between the accuracy of combined transvaginal sonoelastography and abdominal ultrasound versus MRI in diagnosis of cancer cervix, aiming to provide a cheaper alternative to MRI in low resourced counteries
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer cervix
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 16/01/2018
Actual trial start date 16/01/2018
Anticipated date of last follow up 15/07/2018
Actual Last follow-up date 15/07/2018
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group combined transvaginal sonoelastography and abdominopelvic ultrasound then MRI the duration of examination transvaginal sonoelastography + abdomino-pelvic ultrasound then after crossover, MRI abdomen & pelvis 200
Experimental Group MRI then combined transvaginal sonoelastography and abdominopelvic ultrasound after crossover the duration of examination MRI pelvis and abdomen then after crossover, combined transvaginal sonoelastography and abdominopelvic ultrasound after crossover 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
suspicious cervical lesions cervical lesions extending to the vagina Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 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 01/01/2018 Air Force Specialized Hospital
Ethics Committee Address
Street address City Postal code Country
El Teseen 90 street Cairo 63511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diagnosis of suspicious cervical lesions After histo-pathology result
Secondary Outcome Diagnosis of parametrial involvement of cases of cancer cervix After staging of cancer cervix
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Air-Force Specialized Hospital El-Teseen (Ninety) street Cairo Not available Egypt
October 6th University Central axis Cairo Not available Egypt
Al-Galaa Teaching Hospital Al-Galaa street-Downtown Cairo Not available Egypt
AlAzhar University Hospital Downtown- Cairo Cairo none Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Air-Force Specialized Hospital El-Teseen (Ninety) street Cairo Not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Air-Force Specialized Hospital El-Teseen (Ninety) street Cairo Not available Egypt Hospital
Primary Sponsor Octobe 6th University Central axis Cairo Not available Egypt University
COLLABORATORS
Name Street address City Postal code Country
Al-Galaa Teaching Hospital Al-Galaa street-Downtown Cairo Not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 central axis
City Postal code Country Position/Affiliation
Cairo not available Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 central axis
City Postal code Country Position/Affiliation
Cairo not available Egypt October 6th University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 central axis
City Postal code Country Position/Affiliation
Cairo not available Egypt October 6th University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data that underlie the results reported in this article, after deidentification (tables) Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide methodologically sound proposal
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