NCT05291338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

March 12, 2022

Last Update Submit

July 27, 2023

Conditions

Hepatocellular Carcinoma

Keywords

ANG-2IL28Bgenetic polymorphisms

Outcome Measures

Primary Outcomes (2)

  • Angiopoietin (ANG-2) rs55633437.

    Gene

    1 month

  • Interleukin 28 B (IL28B) rs12979860.

    Gene

    1 month

Study Arms (1)

HCC patients

116 hepatocellular carcinoma patients underwent TACE

Drug: DoxorubicinDrug: Lipiodol

Interventions

DoxorubicinDRUG

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

Also known as: Adriamycin
HCC patients
LipiodolDRUG

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.

Also known as: ethiodized oil
HCC patients

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Egyptian HCC patients on doxorubicin and lipiodol treatment

You may qualify if:

  • Eligible patients should fulfill the following criteria:
  • A diagnosed HCC patient.
  • Age ≥20 years.
  • Patients with adequate organ function.
  • HCC not eligible for curative measures (radiofrequency, microwave and surgery).

You may not qualify if:

  • Patient will be excluded for any of the following:
  • Patients refused to sign the written consent.
  • Age \> 75 years.
  • The presence of major portal vein thrombosis.
  • Extrahepatic metastases.
  • Hepatic encephalopathy.
  • Current infection.
  • Gastrointestinal bleeding within a month.
  • Uncontrolled ascites.
  • 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.
  • Patients with other types of malignancy, advanced organ failure, and advanced medical co-morbidity.
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hepatoma group, EL Demerdash Hospital, Cairo, Egypt.

Cairo, Egypt

Location

Related Publications (3)

  • Marisi G, Petracci E, Raimondi F, Faloppi L, Foschi FG, Lauletta G, Iavarone M, Canale M, Valgiusti M, Neri LM, Ulivi P, Orsi G, Rovesti G, Vukotic R, Conti F, Cucchetti A, Ercolani G, Andrikou K, Cascinu S, Scartozzi M, Casadei-Gardini A. ANGPT2 and NOS3 Polymorphisms and Clinical Outcome in Advanced Hepatocellular Carcinoma Patients Receiving Sorafenib. Cancers (Basel). 2019 Jul 20;11(7):1023. doi: 10.3390/cancers11071023.

    PMID: 31330833BACKGROUND

  • Rashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x.

    PMID: 32372179BACKGROUND

  • Werida RH, Abd El Baset OA, Askar S, El-Mohamdy M, Omran GA, Hagag RS. Efficacy of doxorubicin and lipiodol therapy by trans-arterial chemoembolization in hepatocellular carcinoma Egyptian patients and relation to genetic polymorphisms. Expert Rev Anticancer Ther. 2024 Oct;24(10):1009-1020. doi: 10.1080/14737140.2024.2391364. Epub 2024 Aug 21.

    PMID: 39138591DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

DoxorubicinEthiodized Oil

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesIodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Rehab H Werida, Ass Prof.

    Damanhour University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2022

First Posted

March 22, 2022

Study Start

January 1, 2022

Primary Completion

March 31, 2023

Study Completion

April 1, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)