Hepatocellular CarcinomaNCT05047146
The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt
An observational study of Hepatocellular Carcinoma, run by Sadat City University at 1 site in Egypt.
Trial summary
This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma to keep with new challenging in diagnosis and morpho-molecular classifications Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Morphological classifications of HCC
- How many people
- 530 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 31 Jul 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC cases from a single tertiary center eligible for pathological analysis as a primary tool
Who may be able to join
- All pathologically proven Hepatocellular Carcinoma
Who cannot join
- Other malignant tumors than Hepatocellular Carcinoma
- Benign tumor
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma to keep with new challenging in diagnosis and morpho-molecular classifications
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Morphological classifications of HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphological classifications of HCCOther
Morphological classifications of Hepatocellular carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicopathological factors of Hepatocellular Carcinoma
Serum alpha-fetoprotein (AFP) level
Measured: 10 years
Clinicopathological factors of Hepatocellular Carcinoma
Tumor size and focality
Measured: 10 years
Clinicopathological factors of Hepatocellular Carcinoma
Vascular invasion
Measured: 10 years
Clinicopathological factors of Hepatocellular Carcinoma
Pathologic stage and grade
Measured: 10 years
Clinicopathological factors of Hepatocellular Carcinoma
The reserve of background liver
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2021
- Primary completion31 Oct 2021
- Study completion31 Jul 2022
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.
- 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
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047146
- Sponsor's protocol ID
- 00246/2021
- Status last verified
- Oct 2022
- First submitted
- 2 Sep 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing will be by website or google after paper publication
Publications
Sweed D, Sweed E, Moaz I, Mosbeh A, Fayed Y, Elhamed SMA, Sweed E, Macshut M, Abdelsattar S, Kilany S, Saied SA, Badr R, Abdallah MS, Ehsan N. The clinicopathological and prognostic factors of hepatocellular carcinoma: a 10-year tertiary center experience in Egypt. World J Surg Oncol. 2022 Sep 19;20(1):298. doi: 10.1186/s12957-022-02764-2.
PubMed 36117166
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinicopathological and Prognostic Factors of Hepatocellular Carcinoma; 10 Years' Tertiary Center Experience in Egypt
- ClinicalTrials.gov ID
- NCT05047146
- Acronym / sponsor ID
- 00246/2021
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 16 Sep 2021 (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.
This study aimed at study the clinical and pathological criteria of Hepatocellular carcinoma to keep with new challenging in diagnosis and morpho-molecular classifications
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC cases from a single tertiary center eligible for pathological analysis as a primary tool
Key inclusion criteria (1 listed)
- All pathologically proven Hepatocellular Carcinoma
Key exclusion criteria (2 listed)
- Other malignant tumors than Hepatocellular Carcinoma
- Benign tumor
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 |
|---|---|---|
| Morphological classifications of HCCMorphological classifications of Hepatocellular carcinoma | Other | – |
Primary outcome
Clinicopathological factors of Hepatocellular Carcinoma
Time frame: 10 years
Serum alpha-fetoprotein (AFP) level
Clinicopathological factors of Hepatocellular Carcinoma
Time frame: 10 years
Tumor size and focality
Clinicopathological factors of Hepatocellular Carcinoma
Time frame: 10 years
Vascular invasion
Clinicopathological factors of Hepatocellular Carcinoma
Time frame: 10 years
Pathologic stage and grade
Clinicopathological factors of Hepatocellular Carcinoma
Time frame: 10 years
The reserve of background liver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 36117166Sweed D, Sweed E, Moaz I, Mosbeh A, Fayed Y, Elhamed SMA, Sweed E, Macshut M, Abdelsattar S, Kilany S, Saied SA, Badr R, Abdallah MS, Ehsan N. The clinicopathological and prognostic factors of hepatocellular carcinoma: a 10-year tertiary center experience in Egypt. World J Surg Oncol. 2022 Sep 19;20(1):298. doi: 10.1186/s12957-022-02764-2.
- Individual participant dataSharing planned: Yes. sharing will be by website or google after paper publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Sadat City 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 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: finished, as of the sponsor's last update on 25 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicopathological factors of Hepatocellular Carcinoma (time frame: 10 years). The study lists 5 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 NCT05047146, 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 25 Oct 2022.