Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05291338
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2022-03-12
Brief Title:
Pharmacogenetic Study in Hepatocellular Carcinoma Patients
Sponsor:
Rehab Werida
Organization:
Damanhour University
Study Overview
Official Title:
Pharmacogenetic Study in Hepatocellular Carcinoma Patients Underwent TACE
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
evaluate the prognostic value of genetic polymorphisms in HCC Egyptian patients undergoing TACE using lipiodol and doxorubicin
Detailed Description:
Research Objectives This study aims to determine the predictive effect of ANG-2 and IL28B genetic polymorphisms in safety and efficacy of doxorubicin and lipiodol used for the treatment of Egyptian HCC patients Moreover this study will determine the association between genetic polymorphisms of ANG-2 and IL28B with HCC severity
Patients Methods Study design Our study is a prospective study for HCC patients undergoing TACE of doxorubicin and lipiodol
Sample Size Based on previous published incidence of gene it will be at least 116 patients Efficacy and Safety
1 Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors RECIST to 15
Complete response Partial response Progressive disease and Stable disease
2 Repeated TACE sessions will be planned individually based on the tumor response to the treatment protocol
3 Follow up will be performed for detection of tumor size using triphasic CT scan as a measure of efficacy Moreover all patients will be reevaluated for CBC liver and kidney functions in the follow up visit to detect incidence of any adverse effects
4 Patients will be asked for any side effects such as myelosuppression anorexia nausea vomiting andor alopecia
5 Patients will be followed for progression-free survival after receiving TACE
Method Proposal Steps
1 Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy Damanhour University
2 Patients will be recruited from Ain Shams University hepatoma group EL Demerdash Hospital Cairo Egypt
3 At baseline and follow up visits after TACE all patients will be assessed for complete blood count CBC kidney function liver function liver enzymes alpha fetoprotein AFP and viral markers Moreover triphasic pelviabdominal CT will be performed before and after TACE
4 Serum samples will be collected for ANG-2 and IL28B genotyping
5 Genetic polymorphisms of ANG-2 and IL28B will be detected by real time polymerase chain reaction RT-PCR
Five mls of whole blood will be collected then separation of plasma will be performed
Extraction of genomic DNA from blood samples by DNA extraction kit
DNA qualification will be performed by Nano drop
Genotyping will be done by allelic discrimination using Taqman assays specific for each polymorphism
Assays will be done according to manufacturer protocol using real time PCR machine
6 All patients will receive lipiodol and doxorubicin during TACE Doxorubicin dose will differ among patients according to tumor size patient condition patients laboratory data and presence of hepatic arteriovenous fistula
7 Appropriate statistical tests will be conducted to evaluate the significance of the results
8 Results conclusion discussion and recommendations will be given
Patients Methods Study design Our study is a prospective study for HCC patients undergoing TACE of doxorubicin and lipiodol
Sample Size Based on previous published incidence of gene it will be at least 116 patients Efficacy and Safety
1 Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors RECIST to 15
Complete response Partial response Progressive disease and Stable disease
2 Repeated TACE sessions will be planned individually based on the tumor response to the treatment protocol
3 Follow up will be performed for detection of tumor size using triphasic CT scan as a measure of efficacy Moreover all patients will be reevaluated for CBC liver and kidney functions in the follow up visit to detect incidence of any adverse effects
4 Patients will be asked for any side effects such as myelosuppression anorexia nausea vomiting andor alopecia
5 Patients will be followed for progression-free survival after receiving TACE
Method Proposal Steps
1 Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy Damanhour University
2 Patients will be recruited from Ain Shams University hepatoma group EL Demerdash Hospital Cairo Egypt
3 At baseline and follow up visits after TACE all patients will be assessed for complete blood count CBC kidney function liver function liver enzymes alpha fetoprotein AFP and viral markers Moreover triphasic pelviabdominal CT will be performed before and after TACE
4 Serum samples will be collected for ANG-2 and IL28B genotyping
5 Genetic polymorphisms of ANG-2 and IL28B will be detected by real time polymerase chain reaction RT-PCR
Five mls of whole blood will be collected then separation of plasma will be performed
Extraction of genomic DNA from blood samples by DNA extraction kit
DNA qualification will be performed by Nano drop
Genotyping will be done by allelic discrimination using Taqman assays specific for each polymorphism
Assays will be done according to manufacturer protocol using real time PCR machine
6 All patients will receive lipiodol and doxorubicin during TACE Doxorubicin dose will differ among patients according to tumor size patient condition patients laboratory data and presence of hepatic arteriovenous fistula
7 Appropriate statistical tests will be conducted to evaluate the significance of the results
8 Results conclusion discussion and recommendations will be given
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None