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.: PACTR201706002246188 Date of Registration: 01/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MiRna in Breast Cancer
Official scientific title Profiling the circulating miR-639 and miR-10b in Egyptian breast cancer patients
Brief summary describing the background and objectives of the trial Background: Amongst women, breast cancer is the second foremost reason of death globally. MicroRNAs (miRNAs) dysregulation play important role in pathogenesis of breast cancer. There are small number of reports about the comparison of microRNA-639 (miR-639) and microRNA-10b (miR-10b) serum expressions with conventional tumor markers. Objective: This study intended to explore the diagnostic accuracy of circulating miR-639 and miR-10b as a tumor marker in breast cancer and compare with cancer antigen15.3 (CA-15.3) and protein 53 (p53) serum levels.
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 Diagnosis / Prognosis
Anticipated trial start date 03/03/2015
Actual trial start date 04/05/2015
Anticipated date of last follow up 11/08/2015
Actual Last follow-up date 29/05/2015
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
0000-0002-7876-3425 2014-20261
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Serum sample 1 5 Five mL of blood was taken 60 Placebo
Control Group Serum sample No intervention 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All women were initially identified for study participation by physicians at the NCI during (March 2015-August 2015). 2. Participants were all chosen to be female recently diagnosed breast cancer. 3. Patients of various stages not receiving any treatment for this pathologic condition and not have another types of cancer such as (ovarian, uterine, liver, lung, bone¿¿¿. etc.). 1. Patients receiving a chemotherapeutic treatment. 2. Have other types of cancer such as (ovarian, uterine, liver, lung, bone¿. etc.) 3. Pregnant female subjects also excluded. 35 Year(s) 60 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 20/12/2014 NCI ethics committee
Ethics Committee Address
Street address City Postal code Country
Fom El-Khalig square, Kornaish-Elnil, Cairo, Egypt. Cairo 11796 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diagnostic efficacy of miRNAs aganist CA-15.3 and p53 August 2015: results of miRNAs under study assessed for both controls and breast cancer subjects. November 2015: results of miRNAs analyzed and statistical analyzed were done January2016: diagnostic accuracy of miRNAs under study were compared with CA-15.3 and p53.
Secondary Outcome Diagnostic efficacy of miRNAs aganist CA-15.3 and p53 August 2015: results of miRNAs under study assessed for both controls and breast cancer subjects. November 2015: results of miRNAs analyzed and statistical analyzed were done January2016: diagnostic accuracy of miRNAs under study were compared with CA-15.3 and p53.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Instityte Fom El-Khalig square, Kornaish-Elnil, Cairo, Egypt. Cairo 11796 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Fubded Almokhayam Aldaem Street, 6th Province, Nasr City, Cairo, Egypt. Cairo 13465 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al-Azhar University staff member, Ahmed Ismail Almokhayam Aldaem Street, 6th Province, Nasr City, Cairo, Egypt. Cairo 13465 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Al-Azhar University Almokhayam Aldaem Street, 6th Province, Nasr City, Cairo, Egypt. Cairo 13465 Egypt
National Cancer Institute Fom El-Khalig square, Kornaish-Elnil, Cairo, Egypt. Cairo 11796 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abulsoud abulsoudahmed@azhar.edu.eg 00201023203338 Almokhayam Aldaem Street, 6th Province, Nasr City, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo 13465 Egypt Associate Professor of Biochemistry, Biochemistry Dept., Al-Azhar University
Role Name Email Phone Street address
Public Enquiries Ossama Abd El-Motaal ossamamansour1@hotmail.com 00201006180329 Almokhayam Aldaem Street, 6th Province, Nasr City, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo 13465 Egypt Professor of Biochemistry, Biochemistry Dept., Al-Azhar University.
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ismail dr.ahmed882010@yahoo.com 00201140346292 Almokhayam Aldaem Street, 6th Province, Nasr City, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo 13465 Egypt Ass. Lectured of Biochemistry, Biochemistry Dept., Faculty of Pharmacy, Al-Azhar University
REPORTING
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