Dysplastic NoduleNCT07080372
Role of Early API in Accurately Differentiating Hepatocellular Carcinoma From Dysplastic Nodules in Cirrhotic Patients
An observational study of Dysplastic Nodule, run by Superior University at 1 site in Pakistan.
Trial summary
Liver cirrhosis is a common consequence of chronic liver disease, resulting from sustained hepatic injury due to various etiologies. Cirrhosis predisposes individuals to the development of hepatocellular carcinoma (HCC), the most prevalent primary malignancy of the liver. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Dysplastic Nodule
- What is being tested?
- assesment
- How many people
- 73 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Aim of the study: This study aims to assess the role of early arterial phase in detecting and differentiating hepatocellular carcinoma from dysplastic nodules in chronic liver disease patients
Who may be able to join
- Patients with abnormal LFTs
- Liver lesions of various sizes
- Patients with chronic liver disease
- Individuals undergoing routine liver screening
- Willing participants who consent to the study
Who cannot join
- Children less than 5years
- Patients who are allergic or have a history of allergy to contrast media
- Patients with deranged renal function tests
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Early Arterial Phase Imaging in Accurately Differentiating Hepatocellular Carcinoma From Dysplastic Nodules in Cirrhotic Patients
Liver cirrhosis is a common consequence of chronic liver disease, resulting from sustained hepatic injury due to various etiologies. Cirrhosis predisposes individuals to the development of hepatocellular carcinoma (HCC), the most prevalent primary malignancy of the liver. Among cirrhotic patients, distinguishing between hepatocellular carcinoma and dysplastic nodules is crucial for timely diagnosis, treatment planning, and prognostic assessment.
- Conditions
- Dysplastic Nodule
- Being tested
- assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesmentDiagnostic test
This study aims to assess the role of early arterial phase in detecting and differentiating hepatocellular carcinoma from dysplastic nodules in chronic liver disease patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
self administered proforma form
A clinical history form is a structured document used to gather comprehensive information about a patient's medical background and current health status. It typically includes sections for identifying patient demographics, past medical history, family history, social history, medications, allergies, and a detailed account of the current illness or complaint.
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 posted23 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysplastic NoduleStudies 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
- 73 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
- NCT07080372
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/926
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 23 Jul 2025
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Early Arterial Phase Imaging in Accurately Differentiating Hepatocellular Carcinoma From Dysplastic Nodules in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT07080372
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/926
- Conditions
- Dysplastic Nodule
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 23 Jul 2025 (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.
Liver cirrhosis is a common consequence of chronic liver disease, resulting from sustained hepatic injury due to various etiologies. Cirrhosis predisposes individuals to the development of hepatocellular carcinoma (HCC), the most prevalent primary malignancy of the liver. Among cirrhotic patients, distinguishing between hepatocellular carcinoma and dysplastic nodules is crucial for timely diagnosis, treatment planning, and prognostic assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Aim of the study: This study aims to assess the role of early arterial phase in detecting and differentiating hepatocellular carcinoma from dysplastic nodules in chronic liver disease patients
Key inclusion criteria (5 listed)
- Patients with abnormal LFTs
- Liver lesions of various sizes
- Patients with chronic liver disease
- Individuals undergoing routine liver screening
- Willing participants who consent to the study
Key exclusion criteria (4 listed)
- Children less than 5years
- Patients who are allergic or have a history of allergy to contrast media
- Patients with deranged renal function tests
- Pregnant women
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 |
|---|---|---|
| assesmentThis study aims to assess the role of early arterial phase in detecting and differentiating hepatocellular carcinoma from dysplastic nodules in chronic liver disease patients. | Diagnostic test | – |
Primary outcome
self administered proforma form
Time frame: 12 Months
A clinical history form is a structured document used to gather comprehensive information about a patient's medical background and current health status. It typically includes sections for identifying patient demographics, past medical history, family history, social history, medications, allergies, and a detailed account of the current illness or complaint.
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 23 Jul 2025.
- 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 Dysplastic Nodule, 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 5 inclusion and 4 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 23 Jul 2025. 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?
self administered proforma form (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 23 Jul 2025.