NCT05967429

Brief Summary

Evaluating the nutrition status of patients with advanced HCC who received sorafenib. Using the pretreatment nutrition status and quality of life as predictors to sorafenib response

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

July 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

July 21, 2023

Last Update Submit

July 28, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Nutrition assessmentHCCSorafenib

Outcome Measures

Primary Outcomes (3)

  • assessment of nutrition status

    Prognostic nutrition index

    Augest 2023 to March 2024

  • Predictors of sorafenib response

    The neutrophil-to- lymphocyte ratio

    Augest 2023 to March 2024

  • Assess the quality of life

    using FACT Hepatobiliary Symptom Index

    Augest 2023 to March 2024

Study Arms (1)

Hepatocellular carcinoma receiving sorafenib

Patient with advanced stage HCC receiving sorafenib

Diagnostic Test: The neutrophil-to- lymphocyte ratioDiagnostic Test: Prognostic nutrition index

Interventions

The neutrophil-to- lymphocyte ratioDIAGNOSTIC_TEST

It was calculated by dividing the neutrophil count by the lymphocyte count.

Also known as: NLR
Hepatocellular carcinoma receiving sorafenib
Prognostic nutrition indexDIAGNOSTIC_TEST

It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL

Also known as: PNI
Hepatocellular carcinoma receiving sorafenib

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hepatocellular carcinoma patient receiving sorafenib

You may qualify if:

  • HCC recieved sorafenib

You may not qualify if:

  • Patient refuse to participate
  • Patients recieving other treatment modalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Takagi K, Buettner S, Ijzermans JNM. Prognostic significance of the controlling nutritional status (CONUT) score in patients with colorectal cancer: A systematic review and meta-analysis. Int J Surg. 2020 Jun;78:91-96. doi: 10.1016/j.ijsu.2020.04.046. Epub 2020 Apr 23.

    PMID: 32335238BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amr Zagloul, MD

    Sohag University

    STUDY DIRECTOR

  • Ahmed othman, MD

    Sohag University

    STUDY CHAIR

  • Rafat Abd El Aal, MD

    Sohag University

    STUDY CHAIR

Central Study Contacts

Mona Abdelrahmam, MD

CONTACT

01021025895monamohamed@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 1, 2023

Study Start

August 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share