Intrahepatic CholangiocarcinomaNCT05327907
Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
An observational study of Intrahepatic Cholangiocarcinoma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2020to 22 May 2023
- 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: Clinical data of patients in hospitals in the past 10 years were retrospectively collected. Pathological database from September 2010 to July 2021 was searched. Patients with definite pathological diagnosis of ICC or HCC were determined as the training group, and patients from September 2021 to September 2023 were prospectively collected as the validation group.
Who may be able to join
- patients with pathological confirmation of ICC or HCC,
- CT was performed less than 15 days before surgery,
- Patients with complete clinical data.
Who cannot join
- history of other tumors,
- Metastatic liver cancer,
- Patients received preoperative chemotherapy or radiotherapy,
- Image quality analysis is not ideal.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012
Yanjing Gao, PhD.MD, 86-18560086087, gaoyanjing@sdu.edu.cn
About this study
Official title: Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.
Read the detailed description
In recent years, the incidence and mortality of intrahepatic cholangiocarcinoma (ICC) have been increasing worldwide. Due to the different treatment options for hepatocellular carcinoma (HCC) and ICC, accurate differential diagnosis is critical for subsequent treatment of patients. However, because of their similar CT image enhancement patterns, they are easily misdiagnosed by clinicians, leading to an incorrect treatment. Based on the above research background, our objective is to establish a noninvasive method for the diagnosis of ICC and and to construct a differential diagnosis model for ICC and HCC with higher sensitivity and accuracy.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic cholangiocarcinoma, Hepatocellular carcinoma, radiomics, nomogram
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively. | |
| Internal validation cohort | Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively. | |
| External validation cohort | External validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Shandong Province Hospital, Jinan Military General Hospital and Jinan Central Hospital prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.
Measured: through study completion, up to 2 years
sensitivity
Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
Measured: through study completion, up to 2 years
specificity
Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start22 Nov 2020
- Primary completion22 Feb 2023 (estimated)
- Study completion22 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Central Hospital, Shandong Provincial Hospital, Jinan Military General Hospital
- Responsible party
- Principal investigator, Yanjing Gao, Qilu Hospital of Shandong University
- Investigators
- Yanjing Gao, PhD.MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327907
- Sponsor's protocol ID
- 202135719-Qilu
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05327907
- Acronym / sponsor ID
- 202135719-Qilu
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic cholangiocarcinoma, Hepatocellular carcinoma, radiomics, nomogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Jinan Central Hospital, Shandong Provincial Hospital, Jinan Military General Hospital
- Study start
- 22 Nov 2020 (actual)
- Primary completion
- 22 Feb 2023 (estimated)
- Study completion
- 22 May 2023 (estimated)
- First posted
- 14 Apr 2022 (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 purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.
Detailed description
In recent years, the incidence and mortality of intrahepatic cholangiocarcinoma (ICC) have been increasing worldwide. Due to the different treatment options for hepatocellular carcinoma (HCC) and ICC, accurate differential diagnosis is critical for subsequent treatment of patients. However, because of their similar CT image enhancement patterns, they are easily misdiagnosed by clinicians, leading to an incorrect treatment. Based on the above research background, our objective is to establish a noninvasive method for the diagnosis of ICC and and to construct a differential diagnosis model for ICC and HCC with higher sensitivity and accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | –Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively. |
| Internal validation cohort | – | –Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively. |
| External validation cohort | – | –External validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Shandong Province Hospital, Jinan Military General Hospital and Jinan Central Hospital prospectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical data of patients in hospitals in the past 10 years were retrospectively collected. Pathological database from September 2010 to July 2021 was searched. Patients with definite pathological diagnosis of ICC or HCC were determined as the training group, and patients from September 2021 to September 2023 were prospectively collected as the validation group.
Key inclusion criteria (3 listed)
- patients with pathological confirmation of ICC or HCC,
- CT was performed less than 15 days before surgery,
- Patients with complete clinical data.
Key exclusion criteria (4 listed)
- history of other tumors,
- Metastatic liver cancer,
- Patients received preoperative chemotherapy or radiotherapy,
- Image quality analysis is not ideal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy
Time frame: through study completion, up to 2 years
The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.
sensitivity
Time frame: through study completion, up to 2 years
Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
specificity
Time frame: through study completion, up to 2 years
Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
Yanjing Gao, PhD.MD principal investigator
Qilu Hospital of Shandong 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 Intrahepatic Cholangiocarcinoma, run by Qilu Hospital of Shandong University 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 3 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: status not confirmed, as of the sponsor's last update on 14 Apr 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 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 Yanjing Gao, PhD.MD (86-18560086087, gaoyanjing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: through study completion, up to 2 years). The study lists 3 primary outcomes in all. 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 14 Apr 2022.