Brain MRI abnormalities in tuberous sclerosis complex before and after treatment
Design
Randomized clinical trial with control group, with parallel groups, single-blinded
Settings and conduct
The present study will be performed on patients diagnosed with tuberous sclerosis complex in neurology and dermatology clinics of the Tabriz University of Medical Sciences. Patients will be randomly divided into intervention and control groups. Study will be single blonded and the patient outcome assessor as well as the study data analyzer will not be aware of the patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definite diagnosis of tuberous sclerosis complex; Age over 2 years; Stable hemodynamic conditions; Consult to participate in the study
Exclusion criteria: Incidence of drug reactions; Restriction on the use of Everolimus; Cancer; Infectious Disease; Concurrent use of immunosuppressive drugs
Intervention groups
Intervention group: Everolimus drug in the form of 2.5, 5, 7.5 and 10 lets licensed by Swiss company Novartis which will be prescribed 6 months after diagnosis. The dose of the drug will be based on the patient's condition and the physician's discretion.
Main outcome variables
Volume changes in giant astrocytoma and decrease in the volume of subependymal nodules
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180928041159N2
Registration date:2020-01-26, 1398/11/06
Registration timing:prospective
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Sajjad Pourasghary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3667 0577
Email address
pourasghary.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Brain MRI abnormalities in tuberous sclerosis complex before and after treatment
Public title
MRI results in tuberous sclerosis complex before and after treatment
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of tuberous sclerosis complex
Age over 2 years
Stable hemodynamic conditions
Consult to participate in the study
Exclusion criteria:
incidence of drug reactions
Restriction on the use of Everolimus
Cancer
Infectious diseases
Concurrent use of immunosuppressive drugs
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using simple randomization method and random number table tool and patient's ID last four number digits.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient outcome assessor as well as the study data analyzer will not be aware of the patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of Medicine, Golghasht Street, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1118
Health conditions studied
1
Description of health condition studied
Brain MRI abnormalities in tuberous sclerosis complex
ICD-10 code
Q85.1
ICD-10 code description
Tuberous sclerosis
Primary outcomes
1
Description
Volume changes in giant astrocytoma
Timepoint
At baseline, 6 months after receiving everolimus
Method of measurement
Magnetic Resonance Imaging
2
Description
Decrease in the volume of subependymal nodules
Timepoint
At baseline, 6 months after receiving everolimus
Method of measurement
Magnetic Resonance Imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Everolimus drug in the form of 2.5, 5, 7.5 and 10 mg tablets licensed by Swiss company Novartis which will be prescribed for 6 months after diagnosis. The dose of the drug will be based on the patient's condition and the physician's discretion.
Category
Diagnosis
2
Description
Control group: This group will no receive any intervention and will be treated as a control group for 6 months and results will compared with intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Dr. Mohammad Hossein Daghighi
Street address
Golghasht Street, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 0574
Email
imamrezahospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hojjat Pourfathi
Street address
Faculty of Medicine, Near Emamreza Hospital, Golghasht Street, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614743
Phone
+98 41 3337 6923
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leyla Yousefi Halvaie
Position
Clinical Assistant of Radiology
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Faculty of Medicine, Golghasht Street, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 6923
Email
liyousefi511@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Daghighi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Radiology
Street address
Faculty of Medicine, Golghasht Street, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 6923
Email
liyousefi511@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sajjad Pourasghary
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Urjans Street
City
Urmia
Province
West Azarbaijan
Postal code
515588339
Phone
+98 41 3667 0577
Fax
Email
pourasghary.s@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The use request will be emailed to the scientific or public accountability person.