Liver TumorNCT06524557
Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors
An observational study of Liver Tumor, run by Xijing Hospital at 1 site in China.
Trial summary
To explore an effective noninvasive method for differential diagnosis of liver tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Tumor
- What is being tested?
- with chronic liver disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 200 patients whose pathological diagnoses were confirmed by US-guided liver biopsy or surgery and who underwent preoperative conventional US between January 2018 and November 2025 were enrolled in the study.
Who may be able to join
- age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.
Who cannot join
- unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hosptial
Xi'an, Xi'an, 710032
Zhou Huihui, M.M., 15209239680, huihui2807201830@163.com
About this study
Official title: Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
To explore an effective noninvasive method for differential diagnosis of liver tumors.
Read the detailed description
A retrospective study was performed to assess the performance of certain ultrasound-based parameters, in distinguishing benign from malignant with liver biopsy as the gold standard. Demographic data, clinical information and serological data were obtained from participants who were retrospectively enrolled. Receiver operating characteristic (ROC) curve analysis was conducted, including calculation of the optimal area under the ROC curve (AUC), to assess the performance of these measures in distinguishing between benign and malignant in patients with or without chronic liver disease.
- Conditions
- Liver Tumor
- Being tested
- with chronic liver disease
- Keywords
- liver tumors, benign, malignant, Differential diagnosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with chronic liver diseaseDiagnostic test
patients with hepatitis B virus，hepatitis C virus, or other chronic liver disease
| Study group | Role | What they receive |
|---|---|---|
| with chronic liver disease | patients with hepatitis B virus, hepatitis C virus and other chronic liver disease. Receives: Diagnostic Test: with chronic liver disease | |
| without chronic liver disease | patients without hepatitis B virus, hepatitis C virus and other chronic liver disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differential diagnosis of liver tumors
Multimodal ultrasound is of great value in the differential diagnosis of liver tumors
Measured: 2018.01-2025.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jan 2018
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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 Liver TumorStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhou Huihui, M.M., Study chair, Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524557
- Sponsor's protocol ID
- KY-20180101-3
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou H, Sang L, Sun Y, Gong X, Zhang J, Liu L, Wei J, Jiao W, Yu M. Performance of Ultrasonography-Based Fractal Parameters in Distinguishing Hepatocellular Carcinoma From Intrahepatic Cholangiocarcinoma. Ultrason Imaging. 2025 Jul;47(3-4):115-124. doi: 10.1177/01617346251330257. Epub 2025 Apr 15.
PubMed 40231713
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
- ClinicalTrials.gov ID
- NCT06524557
- Acronym / sponsor ID
- KY-20180101-3
- Conditions
- Liver Tumor
- Keywords
- liver tumors, benign, malignant, Differential diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jul 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.
To explore an effective noninvasive method for differential diagnosis of liver tumors.
Detailed description
A retrospective study was performed to assess the performance of certain ultrasound-based parameters, in distinguishing benign from malignant with liver biopsy as the gold standard. Demographic data, clinical information and serological data were obtained from participants who were retrospectively enrolled. Receiver operating characteristic (ROC) curve analysis was conducted, including calculation of the optimal area under the ROC curve (AUC), to assess the performance of these measures in distinguishing between benign and malignant in patients with or without chronic liver disease.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with chronic liver disease | – | Diagnostic Test: with chronic liver diseasepatients with hepatitis B virus, hepatitis C virus and other chronic liver disease. |
| without chronic liver disease | – | –patients without hepatitis B virus, hepatitis C virus and other chronic liver disease. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 patients whose pathological diagnoses were confirmed by US-guided liver biopsy or surgery and who underwent preoperative conventional US between January 2018 and November 2025 were enrolled in the study.
Key inclusion criteria (1 listed)
- age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.
Key exclusion criteria (1 listed)
- unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.
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 |
|---|---|---|
| with chronic liver diseasepatients with hepatitis B virus，hepatitis C virus, or other chronic liver disease | Diagnostic test | with chronic liver disease |
Primary outcome
The differential diagnosis of liver tumors
Time frame: 2018.01-2025.12
Multimodal ultrasound is of great value in the differential diagnosis of liver tumors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 40231713Zhou H, Sang L, Sun Y, Gong X, Zhang J, Liu L, Wei J, Jiao W, Yu M. Performance of Ultrasonography-Based Fractal Parameters in Distinguishing Hepatocellular Carcinoma From Intrahepatic Cholangiocarcinoma. Ultrason Imaging. 2025 Jul;47(3-4):115-124. doi: 10.1177/01617346251330257. Epub 2025 Apr 15.
- 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.
Zhou Huihui, M.M. study chair
Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
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 Liver Tumor, run by Xijing Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 29 Jul 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 China. 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 Zhou Huihui, M.M. (15209239680, huihui2807201830@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differential diagnosis of liver tumors (time frame: 2018.01-2025.12). 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 NCT06524557, 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 29 Jul 2024.