Assessment of plasma expression level of the miRNAs involved in chemo-radiotherapy resistance in response to radiotherapy in non-metastatic neoadjuvant rectal cancer patients using microarray technique
This study is aimed to investigate the plasma expression level of the miRNAs involved in chemo-radiotherapy resistance in response to radiotherapy in non-metastatic neoadjuvant rectal cancer patients using microarray technique. Inclusion criteria is included 55 patients with locally advanced rectal cancer who referred to Firoozgar hospital and Imam Khomeini hospital of Tehran city from summer 2016 until March 2017. Selection of the patients was done randomly and with the written consent. Then, the patients will receive the radiotherapy with the standard dose of 50 Gy divided to 25 sessions (for 5 weeks, 5 sessions per week). The blood samples (10 cc) will be obtained before the radiotherapy, and 6 weeks and 6 months after the radiotherapy. At the beginning and the end of the study, filling the questionnaire, measuring the height and weight and blood sampling will be done by an expert person. Then, the blood plasmas of 10 patients will be evaluated in order to investigate of the changes of miRNAs using microarray technique, and also the evaluation of other samples will be analyzed using Real-Time PCR method in order to verify the results.
General information
Acronym
microRNA and colorectal cancer
IRCT registration information
IRCT registration number:IRCT2016072618745N9
Registration date:2016-07-29, 1395/05/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-29, 1395/05/08
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
2016-06-21, 1395/04/01
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
Assessment of plasma expression level of the miRNAs involved in chemo-radiotherapy resistance in response to radiotherapy in non-metastatic neoadjuvant rectal cancer patients using microarray technique
Public title
Assessment of plasma expression level of some factors involved in chemo-radiotherapy resistance in response to radiotherapy in non-metastatic rectal cancer patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patient with locally advanced rectal cancer; Patient with non-metastatic rectal cancer
Exclusion criteria: Patients with other cancers; Patients with renal and hepatic disorders
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
55
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
2016-04-10, 1395/01/22
Ethics committee reference number
IR.IUMS.REC.1394/19753
Health conditions studied
1
Description of health condition studied
locally advanced rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
the alteration of plasma expression level of the miRNAs
Timepoint
before and after irradation
Method of measurement
microarray technique
Secondary outcomes
1
Description
plasma expression level of the genes
Timepoint
befor and after irradation
Method of measurement
Real-time PCR
Intervention groups
1
Description
The patients will receive the radiotherapy with the standard dose of 50 Gy divided to 25 sessions (for 5 weeks, 5 sessions per week). The blood samples (10 cc) will be obtained before the radiotherapy, and 6 weeks and 6 months after the radiotherapy, and then the blood plasma will be separated.
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