Liver CancerPRIMe-liverNCT05996666
Primary Liver Cancer Early Detection
An observational study of Liver Cancer, run by The First Hospital of Jilin University at 2 sites in China.
Trial summary
In the recently published multi-center, prospective, single-blind study (THUNDER study), using the methylation signal in cfDNA isolated from the peripheral blood to detect the six types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a specificity of 98.9%. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Liver-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 701 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2023to Dec 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants enrolled in this study included subjects with primary liver cancers, benign liver diseases, interfering cancers, and healthy individuals.
Who may be able to join
- Individuals aged 18-74 years old
- Individuals capable of giving signed and legally effective informed consent voluntarily
- Individuals newly diagnosed with or suspected of having liver cancer (including hepatocellular carcinoma [HCC], intrahepatic cholangiocarcinoma [ICC], and combined hepatocellular-cholangiocarcinoma [cHCC-CCA]).
- Individuals without any anti-cancer therapy prior to blood sample collection.
- Inclusion Criteria for participants with benign liver diseases:
- Individuals newly diagnosed as benign liver diseases before blood sample collection
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- Individuals without curative treatment for the disease before blood sample collection
- Inclusion Criteria for participants with interfering cancers:
- Individuals diagnosed with or suspected of having interfering cancer
- Individuals without any anti-cancer therapy prior to blood sample collection
- No cancer-related or other clinical symptoms 30 days prior to blood sample collection
- No prior history of benign liver diseases
Who cannot join
- Individuals cannot provide blood samples at the study-specified blood collection sites
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to blood sample collection
- Recipients of anti-infective treatment within 14 days prior to blood sample collection
- Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
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- Individuals with a history of malignant tumor
- Known prior or current diagnosis of other types of malignancies or multiple primary cancers
- No confirmed diagnosis of liver cancer after blood sample collection
- Exclusion Criteria for participants with benign liver diseases:
- Individuals with a confirmed diagnosis of a malignant tumor or precancerous lesion
- Individuals who cannot be diagnosed as having benign liver diseases after blood sample collection
- Exclusion Criteria for participants with interfering cancers:
- Known prior or current diagnosis of other types of malignancies or multiple primary cancers
- No confirmed diagnosis of any type of interfering cancers after blood sample collection
- Prior or ongoing treatment of cancers within 3 years prior to blood sample collection
- Clinically significant or uncontrolled comorbidities
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Jilin university first hospital
Changchun, Jilin
Bo Liu
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality
Lanqing Yao
About this study
Official title: Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)
In the recently published multi-center, prospective, single-blind study (THUNDER study), using the methylation signal in cfDNA isolated from the peripheral blood to detect the six types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a specificity of 98.9%. In this study, a multicenter, case-control study is designed to establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to detect primary liver cancer and further validate the performance of the model.
- Conditions
- Liver Cancer
- Being tested
- Liver-cancer early detection test
- Keywords
- Early detection, Liver cancer, cell-free DNA (cfDNA), qPCR
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver-cancer early detection testDevice
Blood collection and liver-cancer early detection test
| Study group | Role | What they receive |
|---|---|---|
| Liver cancer arm | Participants with new diagnosis of liver cancer, from whom blood samples will be collected. Receives: Device: Liver-cancer early detection test | |
| Benign diseases arm | Participants with benign diseases of cancer, from whom blood samples will be collected. Receives: Device: Liver-cancer early detection test | |
| Healthy arm | Participants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected. Receives: Device: Liver-cancer early detection test | |
| Interfering cancer arm | Participants with new diagnosis of interfering cancer types, from whom blood samples will be collected. Receives: Device: Liver-cancer early detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR
Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals
Measured: 2023.07.01-2023.12.30
Secondary outcomes (4)
Performance of the liver cancer early detection model in detecting liver cancer at early stage
Sensitivity of the liver cancer early detection model in patients with small liver cancer lesions or AFP negative
Measured: 2023.07.01-2023.12.30
Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes
Sensitivity of the liver cancer early detection model in different stages or different pathological subtypes
Measured: 2023.07.01-2023.12.30
Performance of liver cancer early detection model to differentiate non-liver cancers
Specificity of the liver cancer early detection model to differentiate patients with benign liver diseases or different interfering cancer types from liver cancer
Measured: 2023.07.01-2023.12.30
Comparison of currently used biomarkers for liver cancer detection
Comparison of the sensitivity and specificity of the liver cancer early detection model and other biomarkers of liver cancer in detecting early liver cancer
Measured: 2023.07.01-2023.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jul 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 701 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Principal investigator, Guoyue Lv, The First Hospital of Jilin University
- Investigators
- Tian Yang, Principal investigator, Eastern Hepatobiliary Surgery HospitalNanya Wang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996666
- Sponsor's protocol ID
- RSCD2022015P
- Acronym
- PRIMe-liver
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)
- ClinicalTrials.gov ID
- NCT05996666
- Acronym / sponsor ID
- PRIMe-liver / RSCD2022015P
- Conditions
- Liver Cancer
- Keywords
- Early detection, Liver cancer, cell-free DNA (cfDNA), qPCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 701 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Aug 2023 (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.
In the recently published multi-center, prospective, single-blind study (THUNDER study), using the methylation signal in cfDNA isolated from the peripheral blood to detect the six types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a specificity of 98.9%. In this study, a multicenter, case-control study is designed to establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to detect primary liver cancer and further validate the performance of the model.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Liver cancer arm | – | Device: Liver-cancer early detection testParticipants with new diagnosis of liver cancer, from whom blood samples will be collected. |
| Benign diseases arm | – | Device: Liver-cancer early detection testParticipants with benign diseases of cancer, from whom blood samples will be collected. |
| Healthy arm | – | Device: Liver-cancer early detection testParticipants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected. |
| Interfering cancer arm | – | Device: Liver-cancer early detection testParticipants with new diagnosis of interfering cancer types, from whom blood samples will be collected. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants enrolled in this study included subjects with primary liver cancers, benign liver diseases, interfering cancers, and healthy individuals.
Key inclusion criteria (12 listed)
- Individuals aged 18-74 years old
- Individuals capable of giving signed and legally effective informed consent voluntarily
- Individuals newly diagnosed with or suspected of having liver cancer (including hepatocellular carcinoma [HCC], intrahepatic cholangiocarcinoma [ICC], and combined hepatocellular-cholangiocarcinoma [cHCC-CCA]).
- Individuals without any anti-cancer therapy prior to blood sample collection.
- Individuals newly diagnosed as benign liver diseases before blood sample collection
Key exclusion criteria (17 listed)
- Individuals cannot provide blood samples at the study-specified blood collection sites
- Pregnancy or lactating women
- Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 7 days prior to blood sample collection
- Recipients of anti-infective treatment within 14 days prior to blood sample collection
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 |
|---|---|---|
| Liver-cancer early detection testBlood collection and liver-cancer early detection test | Device | Benign diseases arm, Healthy arm, Interfering cancer arm, Liver cancer arm |
Primary outcome
Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR
Time frame: 2023.07.01-2023.12.30
Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals
4 secondary outcomes
Performance of the liver cancer early detection model in detecting liver cancer at early stage
Time frame: 2023.07.01-2023.12.30
Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes
Time frame: 2023.07.01-2023.12.30
Performance of liver cancer early detection model to differentiate non-liver cancers
Time frame: 2023.07.01-2023.12.30
Comparison of currently used biomarkers for liver cancer detection
Time frame: 2023.07.01-2023.12.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
Tian Yang principal investigator
Eastern Hepatobiliary Surgery Hospital
Nanya Wang principal investigator
The First Hospital of Jilin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by The First Hospital of Jilin University at 2 sites 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 12 inclusion and 17 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Bo Liu (18840110641, liuboliubo1109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR (time frame: 2023.07.01-2023.12.30). 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 18 Aug 2023.