Hepatocellular Carcinoma PatientsNCT05846035
Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients
An observational study of Hepatocellular Carcinoma Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma Patients
- What is being tested?
- Triphasic C.T abdomen and pelvis
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to 30 Apr 2024
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Cirrhotic Patients with HCC. * HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.
Who may be able to join
- - Cirrhotic Patients with HCC.
- HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.
Who cannot join
- - Patient known to have primary parathyroid disease, patients with bone metastasis or excessive use of antacids.
- Patients with secondary polycythemia (as chronic hypoxia) and patients with polycythemia rubra vera.
- Patients with acute infections or GIT bleeding.
- Patients with preexisting dyslipidemia.
- Patients with significant cholestasis.
Trial locations and contacts
1 site in 1 country.
Amr M Zaghloul, Assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Changing epidemiology of HCC is related to trends in these risk factors, Paraneoplastic syndromes (PNS) are defined as systemic, metabolic, or other distant consequences of malignancy resulting, either directly or indirectly, from production by the neoplasm of substances that gain access to the blood stream, thereby exerting their effects on distant organs or tissues There is four major HCC-associated paraneoplastic syndromes among Cirrhotic patients,i.e.hypercholesterolemia,hypoglycemia,hypercalcemia,and erythrocytosis .
- Conditions
- Hepatocellular Carcinoma Patients
- Being tested
- Triphasic C.T abdomen and pelvis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triphasic C.T abdomen and pelvisDiagnostic test
Also called alpha feto protein
for cirrhotic patients to ensure hepatocellular carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of Paraneoplastic Syndrome in cirrhotic Patients with HCC.
To investigate the prevalence of PNS (hypoglycemia, hypercholesterolemia, hypercalcemia, erythrocytosis, and thrombocytosis) and clinical characteristics in cirrhotic Patients with HCC.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Apr 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma PatientsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Maher Abdelhafiz, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846035
- Sponsor's protocol ID
- Soh-Med-23-04-12MS
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borde T, Nezami N, Laage Gaupp F, Savic LJ, Taddei T, Jaffe A, Strazzabosco M, Lin M, Duran R, Georgiades C, Hong K, Chapiro J. Optimization of the BCLC Staging System for Locoregional Therapy for Hepatocellular Carcinoma by Using Quantitative Tumor Burden Imaging Biomarkers at MRI. Radiology. 2022 Jul;304(1):228-237. doi: 10.1148/radiol.212426. Epub 2022 Apr 12.
PubMed 35412368Qu Q, Wang S, Chen S, Zhou L, Rui JA. Prognostic role and significance of paraneoplastic syndromes in hepatocellular carcinoma. Am Surg. 2014 Feb;80(2):191-6.
PubMed 24480222Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08.
PubMed 34422400
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT05846035
- Acronym / sponsor ID
- Soh-Med-23-04-12MS
- Conditions
- Hepatocellular Carcinoma Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 May 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.
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Changing epidemiology of HCC is related to trends in these risk factors, Paraneoplastic syndromes (PNS) are defined as systemic, metabolic, or other distant consequences of malignancy resulting, either directly or indirectly, from production by the neoplasm of substances that gain access to the blood stream, thereby exerting their effects on distant organs or tissues There is four major HCC-associated paraneoplastic syndromes among Cirrhotic patients,i.e.hypercholesterolemia,hypoglycemia,hypercalcemia,and erythrocytosis .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Cirrhotic Patients with HCC. * HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.
Key inclusion criteria (2 listed)
- - Cirrhotic Patients with HCC.
- HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.
Key exclusion criteria (5 listed)
- - Patient known to have primary parathyroid disease, patients with bone metastasis or excessive use of antacids.
- Patients with secondary polycythemia (as chronic hypoxia) and patients with polycythemia rubra vera.
- Patients with acute infections or GIT bleeding.
- Patients with preexisting dyslipidemia.
- Patients with significant cholestasis.
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 |
|---|---|---|
| Triphasic C.T abdomen and pelvisAlso: alpha feto proteinfor cirrhotic patients to ensure hepatocellular carcinoma | Diagnostic test | – |
Primary outcome
the prevalence of Paraneoplastic Syndrome in cirrhotic Patients with HCC.
Time frame: 12 months
To investigate the prevalence of PNS (hypoglycemia, hypercholesterolemia, hypercalcemia, erythrocytosis, and thrombocytosis) and clinical characteristics in cirrhotic Patients with HCC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 35412368Borde T, Nezami N, Laage Gaupp F, Savic LJ, Taddei T, Jaffe A, Strazzabosco M, Lin M, Duran R, Georgiades C, Hong K, Chapiro J. Optimization of the BCLC Staging System for Locoregional Therapy for Hepatocellular Carcinoma by Using Quantitative Tumor Burden Imaging Biomarkers at MRI. Radiology. 2022 Jul;304(1):228-237. doi: 10.1148/radiol.212426. Epub 2022 Apr 12.
- Background: PubMed 24480222Qu Q, Wang S, Chen S, Zhou L, Rui JA. Prognostic role and significance of paraneoplastic syndromes in hepatocellular carcinoma. Am Surg. 2014 Feb;80(2):191-6.
- Background: PubMed 34422400Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08.
- Individual participant dataSharing planned: Undecided
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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 M Zaghloul, Assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Patients, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 5 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hala M Abdelhafeez, Resident (01027319657, halamaher@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of Paraneoplastic Syndrome in cirrhotic Patients with HCC. (time frame: 12 months). 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 NCT05846035, which also lists 3 linked publications.
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 6 May 2023.