Hepatocellular CarcinomaNCT05967429
Predictors of Sorafenib Response in HCC
An observational study of Hepatocellular Carcinoma, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- The neutrophil-to- lymphocyte ratio and Prognostic nutrition index
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jun 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Hepatocellular carcinoma patient receiving sorafenib
Who may be able to join
- HCC recieved sorafenib
Who cannot join
- Patient refuse to participate
- Patients recieving other treatment modalities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma
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
Read the detailed description
This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were gathered from medical records, including
age sex body weight and height (BMI) pre-therapy laboratory counts of white cells, neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin concentration, AST, ALT, AFP, PT and CONC
Barcelona Clinic Liver Cancer Stage (BCLC) of all patients
The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by the lymphocyte count.
The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the lymphocyte count.
Weight loss difference after treatment Portal hypertension was defined as presence of either collaterals on radiological examination, esophageal varices by upper gastrointestinal endoscopy and/or thrombocytopenia.
Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8) Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- The neutrophil-to- lymphocyte ratio, Prognostic nutrition index
- Keywords
- Nutrition assessment, HCC, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The neutrophil-to- lymphocyte ratioDiagnostic test
Also called NLR
It was calculated by dividing the neutrophil count by the lymphocyte count.
Prognostic nutrition indexDiagnostic test
Also called PNI
It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma receiving sorafenib | Patient with advanced stage HCC receiving sorafenib Receives: Diagnostic Test: The neutrophil-to- lymphocyte ratio; Diagnostic Test: Prognostic nutrition index |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of nutrition status
Prognostic nutrition index
Measured: Augest 2023 to March 2024
Predictors of sorafenib response
The neutrophil-to- lymphocyte ratio
Measured: Augest 2023 to March 2024
Assess the quality of life
using FACT Hepatobiliary Symptom Index
Measured: Augest 2023 to March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Abdelrhman, Sohag University
- Investigators
- Amr Zagloul, MD, Study director, Sohag UniversityAhmed othman, MD, Study chair, Sohag UniversityRafat Abd El Aal, MD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967429
- Sponsor's protocol ID
- Soh-Med-23-07-07PD
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32335238
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05967429
- Acronym / sponsor ID
- Soh-Med-23-07-07PD
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Nutrition assessment, HCC, Sorafenib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were gathered from medical records, including
age sex body weight and height (BMI) pre-therapy laboratory counts of white cells, neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin concentration, AST, ALT, AFP, PT and CONC
Barcelona Clinic Liver Cancer Stage (BCLC) of all patients
The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by the lymphocyte count.
The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the lymphocyte count.
Weight loss difference after treatment Portal hypertension was defined as presence of either collaterals on radiological examination, esophageal varices by upper gastrointestinal endoscopy and/or thrombocytopenia.
Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8) Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma receiving sorafenib | – | Diagnostic Test: The neutrophil-to- lymphocyte ratio, Diagnostic Test: Prognostic nutrition indexPatient with advanced stage HCC receiving sorafenib |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hepatocellular carcinoma patient receiving sorafenib
Key inclusion criteria (1 listed)
- HCC recieved sorafenib
Key exclusion criteria (2 listed)
- Patient refuse to participate
- Patients recieving other treatment modalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The neutrophil-to- lymphocyte ratioAlso: NLRIt was calculated by dividing the neutrophil count by the lymphocyte count. | Diagnostic test | Hepatocellular carcinoma receiving sorafenib |
| Prognostic nutrition indexAlso: PNIIt was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL | Diagnostic test | Hepatocellular carcinoma receiving sorafenib |
Primary outcome
assessment of nutrition status
Time frame: Augest 2023 to March 2024
Prognostic nutrition index
Predictors of sorafenib response
Time frame: Augest 2023 to March 2024
The neutrophil-to- lymphocyte ratio
Assess the quality of life
Time frame: Augest 2023 to March 2024
using FACT Hepatobiliary Symptom Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 32335238Takagi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Zagloul, MD study director
Sohag University
Ahmed othman, MD study chair
Sohag University
Rafat Abd El Aal, MD study chair
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Abdelrahmam, MD (01021025895, monamohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of nutrition status (time frame: Augest 2023 to March 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.