Focal Liver LesionsGUIDERNCT05393102
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
An observational study of Focal Liver Lesions, run by The Second Affiliated Hospital of Chongqing Medical University at 3 sites in China.
Trial summary
As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Liver Lesions
- How many people
- 400 participants
- Where
- 3 sitesChina
- Study dates
- May 2022to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four hundreds eligible participants will be recruited from medical centers and assigned into three groups, including participants with malignant or benign liver nodules，and participants with uncertain liver nodules.
Who may be able to join
- Eighteen years or elder；
- Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；
- Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；
- Participants who are willing and able to perform hepatectomy or tissure biopsy.
Who cannot join
- Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；
- Diagnosis of malignant tumors before recruitment；
- Anti-tumor therapy before recruitment ；
- HIV infection；
- Pregnancy；
- Allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection;
- Participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage.
- Participants with any other factors that may leading to termination of the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jinlin Hou, MD, 13802727354, jlhousmu@163.com
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Hongyang Wang, MD, 86 21 81875361, hywangk@vip.sina.com
Lei Chen, MD, 86 13918939969, chenlei@smmu.edu.cn
About this study
Official title: Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes (GUDIER): an Observational Cohort Trial
As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.
Read the detailed description
Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.
- Conditions
- Focal Liver Lesions
- Being tested
- No interventions
- Keywords
- hepatocellular carcinoma, liver nodules, auxiliary diagnosis, liquid biopsy, peripheral blood, cfDNA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Malignant liver nodules cohort | Participants with malignant liver nodules diagnosed by pathological biopsy. Receives: Other: No interventions | |
| Benign liver nodules cohort | Participants with benign liver nodules diagnosed by pathological biopsy or imaging examination. Receives: Other: No interventions | |
| Uncertain benign or malignant liver nodules cohort | Participants with liver nodules could not be diagnosed definitely by imaging examination and serum protein markers. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.
Measured: Enrollment of the first participant up to 18 months
Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.
Measured: Enrollment of the first participant up to 18 months
Secondary outcomes (1)
Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.
Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by the model that composed of cfDNA whole-genome signatures, imaging examination，serum protein markers， and clinical characteristics.
Measured: Through study completion，an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study startMay 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Focal Liver LesionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Principal investigator, Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Hong Ren, MD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical UniversityHongyang Wang, MD, Principal investigator, Eastern Hepatobiliary Surgery HospitaJinlin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393102
- Sponsor's protocol ID
- 2022-20
- Acronym
- GUIDER
- Status last verified
- May 2022
- First submitted
- 8 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Kobayashi M, Ikeda K, Hosaka T, Sezaki H, Someya T, Akuta N, Suzuki F, Suzuki Y, Saitoh S, Arase Y, Kumada H. Dysplastic nodules frequently develop into hepatocellular carcinoma in patients with chronic viral hepatitis and cirrhosis. Cancer. 2006 Feb 1;106(3):636-47. doi: 10.1002/cncr.21607.
PubMed 16369988Llovet JM, Chen Y, Wurmbach E, Roayaie S, Fiel MI, Schwartz M, Thung SN, Khitrov G, Zhang W, Villanueva A, Battiston C, Mazzaferro V, Bruix J, Waxman S, Friedman SL. A molecular signature to discriminate dysplastic nodules from early hepatocellular carcinoma in HCV cirrhosis. Gastroenterology. 2006 Dec;131(6):1758-67. doi: 10.1053/j.gastro.2006.09.014. Epub 2006 Sep 19.
PubMed 17087938Chen L, Abou-Alfa GK, Zheng B, Liu JF, Bai J, Du LT, Qian YS, Fan R, Liu XL, Wu L, Hou JL, Wang HY; PreCar Team. Genome-scale profiling of circulating cell-free DNA signatures for early detection of hepatocellular carcinoma in cirrhotic patients. Cell Res. 2021 May;31(5):589-592. doi: 10.1038/s41422-020-00457-7. Epub 2021 Feb 15. No abstract available.
PubMed 33589745
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes (GUDIER): an Observational Cohort Trial
- ClinicalTrials.gov ID
- NCT05393102
- Acronym / sponsor ID
- GUIDER / 2022-20
- Conditions
- Focal Liver Lesions
- Keywords
- hepatocellular carcinoma, liver nodules, auxiliary diagnosis, liquid biopsy, peripheral blood, cfDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, Nanfang Hospital, Southern Medical University
- Study start
- May 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 May 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.
As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.
Detailed description
Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malignant liver nodules cohort | – | Other: No interventionsParticipants with malignant liver nodules diagnosed by pathological biopsy. |
| Benign liver nodules cohort | – | Other: No interventionsParticipants with benign liver nodules diagnosed by pathological biopsy or imaging examination. |
| Uncertain benign or malignant liver nodules cohort | – | Other: No interventionsParticipants with liver nodules could not be diagnosed definitely by imaging examination and serum protein markers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four hundreds eligible participants will be recruited from medical centers and assigned into three groups, including participants with malignant or benign liver nodules，and participants with uncertain liver nodules.
Key inclusion criteria (4 listed)
- Eighteen years or elder；
- Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；
- Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；
- Participants who are willing and able to perform hepatectomy or tissure biopsy.
Key exclusion criteria (8 listed)
- Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；
- Diagnosis of malignant tumors before recruitment；
- Anti-tumor therapy before recruitment ；
- HIV infection；
- Pregnancy；
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 |
|---|---|---|
| No interventionsNo interventions | Other | Benign liver nodules cohort, Malignant liver nodules cohort, Uncertain benign or malignant liver nodules cohort |
Primary outcome
Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
Time frame: Enrollment of the first participant up to 18 months
Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.
Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
Time frame: Enrollment of the first participant up to 18 months
Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.
1 secondary outcome
Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.
Time frame: Through study completion，an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 16369988Kobayashi M, Ikeda K, Hosaka T, Sezaki H, Someya T, Akuta N, Suzuki F, Suzuki Y, Saitoh S, Arase Y, Kumada H. Dysplastic nodules frequently develop into hepatocellular carcinoma in patients with chronic viral hepatitis and cirrhosis. Cancer. 2006 Feb 1;106(3):636-47. doi: 10.1002/cncr.21607.
- Background: PubMed 17087938Llovet JM, Chen Y, Wurmbach E, Roayaie S, Fiel MI, Schwartz M, Thung SN, Khitrov G, Zhang W, Villanueva A, Battiston C, Mazzaferro V, Bruix J, Waxman S, Friedman SL. A molecular signature to discriminate dysplastic nodules from early hepatocellular carcinoma in HCV cirrhosis. Gastroenterology. 2006 Dec;131(6):1758-67. doi: 10.1053/j.gastro.2006.09.014. Epub 2006 Sep 19.
- Background: PubMed 33589745Chen L, Abou-Alfa GK, Zheng B, Liu JF, Bai J, Du LT, Qian YS, Fan R, Liu XL, Wu L, Hou JL, Wang HY; PreCar Team. Genome-scale profiling of circulating cell-free DNA signatures for early detection of hepatocellular carcinoma in cirrhotic patients. Cell Res. 2021 May;31(5):589-592. doi: 10.1038/s41422-020-00457-7. Epub 2021 Feb 15. No abstract available.
- 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.
Hong Ren, MD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
Hongyang Wang, MD principal investigator
Eastern Hepatobiliary Surgery Hospita
Jinlin Hou, MD principal investigator
Nanfang Hospital, Southern Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Liver Lesions, run by The Second Affiliated Hospital of Chongqing Medical University at 3 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 4 inclusion and 8 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 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Hong Ren, MD (13983888786, renhong0531@vip.sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis. (time frame: Enrollment of the first participant up to 18 months). The study lists 2 primary outcomes in all. 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 NCT05393102, which also lists 4 linked publications.
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 26 May 2022.