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The expression level alterations of miRNAs 21, 155, 10b and Let-7a, and matrix metalloproteinases 1, 2, 9, 11 and 13 as biomarkers in response to surgery and chemotherapy in blood plasma of breast cancer patients

Protocol summary

Summary
One of the important problems in cancer treatment is its diagnosis in the early stages and evaluation of response to treatment. Therefore, using the appropriate diagnostic methods with high efficiency and proper biomarkers for diagnosis and treatment of cancer patients is necessary. The present study aims to evaluate the expression level alterations of miRNAs 21, 155, 10b and Let-7a, and also the blood plasma-derived Matrix metalloproteinases 1, 2, 9, 11 and 13 in breast cancer patients. Inclusion criteria are included 30 breast cancer patients who will refer to Cancer Institute of Imam Khomeini hospital from October 2016 until October 2017. After inclusion, 5 ml whole blood will be collected from all the patients in both stages of diagnosis and after the treatment (after surgery and chemotherapy). After centrifugation, all samples will be maintained at -80 °C until the assessment time. Then, RNA extraction from blood and tissue, cDNA synthesis and quantitative analyses for the expressions of miRNAs 10b, 155, 21 and Let-7a, and also Matrix metalloproteinases 1, 2, 9, 11 and 13 will be performed by gelatin quantitative zymography.

General information

Acronym
MicroRNAs; Metalloproteinases
IRCT registration information
IRCT registration number: IRCT2016080818745N11
Registration date: 2016-09-04, 1395/06/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The expression level alterations of miRNAs 21, 155, 10b and Let-7a, and matrix metalloproteinases 1, 2, 9, 11 and 13 as biomarkers in response to surgery and chemotherapy in blood plasma of breast cancer patients
Public title
The expression level alterations of some biofactors as biomarkers in response to surgery and chemotherapy in blood plasma of breast cancer patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: The patients with breast cancer; With written informed consent; 30-70 years old patients; The breast cancer patients in stages 2 and 3. Exclusion criteria: The patients with opioid addiction; The patients with the history of rheumatoid arthritis; The patients with the history of cancer.
Age
From 30 years old to 70 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Bulvar, Porsina Street
City
Tehran
Postal code
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.TUMS.REC.1395.2800

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified

Primary outcomes

1

Description
the alteration of plasma expression level of the miRNAs
Timepoint
before and after treatment
Method of measurement
Real-Time PCR

Secondary outcomes

1

Description
the expressions of metalloproteinases level
Timepoint
befor and after treatment
Method of measurement
Gelatin quantitative zymography

Intervention groups

1

Description
Five ml whole blood of all patients will be collected in both stages of disease diagnosis and after the standard treatments.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Uonesian
Street address
Keshavarz Bulvar, Porsina Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Person responsible for updating data

Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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