Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06030895
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-09-03
Brief Title:
Sorafenib In Egyptian Patients With Hepatocellular Carcinoma
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This study aims to determine the predictive effect of ATG10 and IL6 genetic polymorphisms in safety and efficacy of sorafenib used for the treatment of Egyptian HCC patients Moreover this study will determine the association between genetic polymorphisms of ATG10 and IL6 with HCC severity
Detailed Description:
A prospective pharmcogentic study for Egyptian HCC patients treating with oral sorafenib
1 Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy Damanhour University
2 100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed 400 mg twice daily or 200mg twice daily will be recruited from Mansoura University Hospital Mansoura Egypt
3 At baseline and follow up visits after Sorafenib 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
4 Blood samples will be collected for ATG10 AND IL6 genotyping
5 Genetic polymorphisms of ATG10 AND IL6 will be detected by real time polymerase chain reaction RT-PCR
Five mls of whole blood will be collected
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 Appropriate statistical tests will be conducted to evaluate the significance of the results
7 Results conclusion discussion and recommendations will be given Ethical Issue
Informed consent will be signed by all eligible patients before enrolling in the study
All patients data will be confidential
Efficacy and Safety outcomes
1 Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors mRECIST Complete response Partial response Progressive disease and Stable disease
2 The appropriate dose of sorafenib will be determined individually based on the patient tolerability
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 CBCAFP 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 diarrhea anorexia nausea vomiting
5 Patients will be followed for progression-free survival after receiving soarfenib
1 Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy Damanhour University
2 100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed 400 mg twice daily or 200mg twice daily will be recruited from Mansoura University Hospital Mansoura Egypt
3 At baseline and follow up visits after Sorafenib 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
4 Blood samples will be collected for ATG10 AND IL6 genotyping
5 Genetic polymorphisms of ATG10 AND IL6 will be detected by real time polymerase chain reaction RT-PCR
Five mls of whole blood will be collected
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 Appropriate statistical tests will be conducted to evaluate the significance of the results
7 Results conclusion discussion and recommendations will be given Ethical Issue
Informed consent will be signed by all eligible patients before enrolling in the study
All patients data will be confidential
Efficacy and Safety outcomes
1 Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors mRECIST Complete response Partial response Progressive disease and Stable disease
2 The appropriate dose of sorafenib will be determined individually based on the patient tolerability
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 CBCAFP 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 diarrhea anorexia nausea vomiting
5 Patients will be followed for progression-free survival after receiving soarfenib
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