Hepatocellular CarcinomaNCT06748755
A Comparative Analysis of Ultrasound's Accuracy in Diagnosing HC Using Histopathology as Gold Standard
An observational study of Hepatocellular Carcinoma, run by Superior University at 1 site in Pakistan.
Trial summary
The study aims to evaluate the accuracy of ultrasound in diagnosing hepatocellular carcinoma (HCC), using histopathology as the gold standard. It addresses HCC's high global incidence and the utility of ultrasound as a non-invasive, cost-effective screening tool. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Group 1
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 20 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: aim is to check the accuracy of Ultrasound's in Diagnosing Hepatocellular Carcinoma Using Histopathology as Gold Standard
Who may be able to join
- Clinically suspected liver cancer patients undergoing ultrasound examination.
- Patients undergoing histopathological examination (liver biopsy or resection) for definitive diagnosis.
Who cannot join
- Patients with history of liver cancer treatment or inadequate data."
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medcare International Hospital
Chak One Hundred Seventy-five Nine Left, Punjab Province
About this study
Official title: A Comparative Analysis of Ultrasound's Accuracy in Diagnosing Hepatocellular Carcinoma Using Histopathology as Gold Standard
The study aims to evaluate the accuracy of ultrasound in diagnosing hepatocellular carcinoma (HCC), using histopathology as the gold standard. It addresses HCC's high global incidence and the utility of ultrasound as a non-invasive, cost-effective screening tool. Despite ultrasound's accessibility, its diagnostic limitations necessitate further investigation to improve clinical outcomes.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Group 1
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Radiation
To determine the sensitivity of ultrasound in detecting HCC
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound
Sensitivity and Specificity analysis of Ultrasound as diagnostic tool, with histopathology as gold standard.
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 posted27 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Superior 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-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748755
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/047
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Ultrasound's Accuracy in Diagnosing Hepatocellular Carcinoma Using Histopathology as Gold Standard
- ClinicalTrials.gov ID
- NCT06748755
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/047
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
The study aims to evaluate the accuracy of ultrasound in diagnosing hepatocellular carcinoma (HCC), using histopathology as the gold standard. It addresses HCC's high global incidence and the utility of ultrasound as a non-invasive, cost-effective screening tool. Despite ultrasound's accessibility, its diagnostic limitations necessitate further investigation to improve clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- aim is to check the accuracy of Ultrasound's in Diagnosing Hepatocellular Carcinoma Using Histopathology as Gold Standard
Key inclusion criteria (2 listed)
- Clinically suspected liver cancer patients undergoing ultrasound examination.
- Patients undergoing histopathological examination (liver biopsy or resection) for definitive diagnosis.
Key exclusion criteria (1 listed)
- Patients with history of liver cancer treatment or inadequate data."
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 |
|---|---|---|
| Group 1To determine the sensitivity of ultrasound in detecting HCC | Radiation | – |
Primary outcome
ultrasound
Time frame: 12 Months
Sensitivity and Specificity analysis of Ultrasound as diagnostic tool, with histopathology as gold standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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.
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 Superior University at 1 site in Pakistan.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
ultrasound (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.