Pharmacogenetic Study in Hepatocellular Carcinoma Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

evaluate the prognostic value of genetic polymorphisms in HCC Egyptian patients undergoing TACE using lipiodol and doxorubicin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

NCT06527495

HCC Hepatocellular Carcinoma

RECRUITING PHASE1/PHASE2

Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.

NCT06030895

Hepatocellular Carcinoma

COMPLETED NA

Pharmacogenetic of Doxorubicin in HCC.

NCT06313047

Hepatocellular Carcinoma

COMPLETED

Study of TAC-101 as Second Line Treatment in Patients With Advanced Hepatocellular Carcinoma Who Received Sorafenib as First Line Therapy

NCT00687596

Hepatocellular Carcinoma

TERMINATED PHASE2

Survival Analysis: TACE vs. Combination Therapy in HCC

NCT06261138

Hepatocellular Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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, and/or 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, patient's 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HCC patients

116 hepatocellular carcinoma patients underwent TACE

Doxorubicin

Intervention Type DRUG

no optimal dosage of doxorubicin in TACE procedures (ranging from 30 to 75 mg/m2 up to a maximum of 150 mg/m2 ) according to tumor size

Lipiodol

Intervention Type DRUG

Lipiodol dose should be over 5 ml if tumor diameter is less than 5 cm, and the maximum dose will be 10 ml when the tumor develops to more than 5 cm in diameter.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxorubicin

no optimal dosage of doxorubicin in TACE procedures (ranging from 30 to 75 mg/m2 up to a maximum of 150 mg/m2 ) according to tumor size

Intervention Type DRUG

Lipiodol

Lipiodol dose should be over 5 ml if tumor diameter is less than 5 cm, and the maximum dose will be 10 ml when the tumor develops to more than 5 cm in diameter.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Adriamycin ethiodized oil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Eligible patients should fulfill the following criteria:

1. A diagnosed HCC patient.
2. Age ≥20 years.
3. Patients with adequate organ function.
4. HCC not eligible for curative measures (radiofrequency, microwave and surgery).

Exclusion Criteria

* Patient will be excluded for any of the following:

1. Patients refused to sign the written consent.
2. Age \> 75 years.
3. The presence of major portal vein thrombosis.
4. Extrahepatic metastases.
5. Hepatic encephalopathy.
6. Current infection.
7. Gastrointestinal bleeding within a month.
8. Uncontrolled ascites.
9. Serum bilirubin \> 3.0 mg/dl, serum albumin \< 2.8 g/dl, serum creatinine concentration \> 1.5 mg/dl, white blood cell counts \< 3,000/mm3 and platelet counts \< 30,000/mm3.
10. Patients with other types of malignancy, advanced organ failure, and advanced medical co-morbidity.
11. Pregnant females.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No