Carcinoma, HepatocellularPRECARNCT03588442
Prospective Surveillance for Very Early Hepatocellular Carcinoma
An observational study of Carcinoma, Hepatocellular, run by Eastern Hepatobiliary Surgery Hospital at 13 sites in China.
Trial summary
Hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. Early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- How many people
- 10,000 participants
- Where
- 13 sitesChina
- Study dates
- 15 Jul 2018to 15 Jul 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhosis cohort: patients with liver cirrhosis. HBV infection cohort: patients with chronic HBV infection.
Who may be able to join
- -
- [1] Cirrhosis cohort
- Age within 30 to 75 years.
- Diagnosis of liver cirrhosis within recent 6 months.
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- Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6.
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- No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage.
- Satisfying equal to or more than 2 of below conditions.
- Imaging studies indicating characteristics of liver cirrhosis: irregular liver surface, liver parenchyma particles or nodules, intraperitoneal collateral circulation, or varicose veins with or without splenomegaly (more than 4 cm or 5 ribs).
- Platelet count < 200 x 10^9/L.
- Alanine aminotransferase < 5 folds of normal level and liver hardness > 12 kPa.
- Gastroesophageal varices from endoscopy or imaging studies.
- [2] HBV infection cohort
- Age within 40 to 70 years
- Chronic HBV infection (seropositive for HBsAg over 6 months).
Who cannot join
- Cirrhosis cohort
- Child-Pugh score of C.
- Hereditary metabolic liver diseases.
- Presence of HIV-Ab.
- Previous diagnosis of active pulmonary tuberculosis.
- Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.
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- Patients who had received allogeneic blood transfusion or cell therapy within 1 year.
- Pregnant women.
- [2] HBV infection cohort
- Autoimmune liver diseases.
- Hereditary metabolic liver diseases.
- Other chronic liver diseases, such as flukes.
- Presence of HCV, HDV, HEV, or HIV infection.
- Previous diagnosis of active pulmonary tuberculosis.
- Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.
- Patients who had received allogeneic blood transfusion or cell therapy within 1 year.
- Pregnant women.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
The First Bethune of Jilin University
Changchun, Jilin, 130021
Yanhang Gao, MD, 15804303019, 15804303019@163.com
- Recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000
Yanlong Yu, MM, 15247666626, yuyanlong1895@163.com
- Recruiting
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038
Xiaomei Xiang, BM, 15023263301, xiangxiaomei413@sina.cn
- Recruiting
Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University
Fuzhou, Fujian, 350025
Xiaolong Liu, MD, 13313975783, xiaoloong.liu@foxmail.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Rong Fan, MD, 13143522264, rongfansmu@163.com
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250000
Lutao Du, MD, 13573132466, dulutao1984@163.com
- Recruiting
HwaMei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315000
Xudong Zhao, MD, 15990575156, zhaoxudong120@sina.com
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200000
Jiao Liu, MD, 18930328039, liujiao8812@163.com
- Recruiting
Shanghai Oriental Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Hui Wang, MD, 13816444416, 13816444416@163.com
- Recruiting
First Affiliated Hospital, Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Hali Da, MM, 18509914924, 28043284@qq.com
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Min Du, PhD, 15926366269, treacy29@163.com
- Recruiting
Xuzhou No.1 People's Hospital
Xuzhou, Jiangsu, 221002
Xiaoqian Liu, MM, 13952173003, zbliuxiaoqian@126.com
- Recruiting
Xuzhou Infectious Disease Hospital
Xuzhou, Jiangsu, 221004
Zhanzhong Liu, PhD, 18352222280, Zhanzhong.liu@foxmail.com
About this study
Official title: Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
Hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. Early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. Herein, we intended to establish a biosignature for early diagnosis of hepatocellular carcinoma and stratification of risk population for intensive follow-up by implementing biannual follow-up investigation and collecting peripheral blood samples for screening.
Read the detailed description
Patients will be recruited for 1 year and be follow-up for 3 years. Patients will make active hospital visit for collection of blood samples, which will be analyzed to develop a biosignature at the end of the study to detect very early hepatocellular carcinoma and stratify risk population for intensive follow-up.
- Conditions
- Carcinoma, Hepatocellular
- Medical subject headings
- 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 |
|---|---|---|
| Cirrhosis cohort | Patients with liver cirrhosis. | |
| HBV infection cohort | Patients with seropositivity of HBsAg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatocellular carcinoma
Development of hepatocellular carcinoma
Measured: July 2018 to July 2022
Overall survival
Death
Measured: July 2018 to July 2022
Liver-related disease progression
HBV and cirrhosis progression
Measured: July 2018 to July 2022
Secondary outcomes (1)
Non-hepatocellular carcinoma malignant neoplasm
Development of other primary liver cancer, such as Intrahepatic cholangiocarcinoma.
Measured: July 2018 to July 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start15 Jul 2018
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2023 (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 Carcinoma, HepatocellularStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Chen, PhD, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Hongyang Wang, MD and PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, ChinaJinlin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588442
- Sponsor's protocol ID
- 2018ZX10732202
- Acronym
- PRECAR
- Status last verified
- May 2020
- First submitted
- 1 Jul 2018
- Last updated
- 22 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xing X, Cai L, Ouyang J, Wang F, Li Z, Liu M, Wang Y, Zhou Y, Hu E, Huang C, Wu L, Liu J, Liu X. Proteomics-driven noninvasive screening of circulating serum protein panels for the early diagnosis of hepatocellular carcinoma. Nat Commun. 2023 Dec 18;14(1):8392. doi: 10.1038/s41467-023-44255-2.
PubMed 38110372
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
- ClinicalTrials.gov ID
- NCT03588442
- Acronym / sponsor ID
- PRECAR / 2018ZX10732202
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 17 Jul 2018 (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.
Hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. Early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. Herein, we intended to establish a biosignature for early diagnosis of hepatocellular carcinoma and stratification of risk population for intensive follow-up by implementing biannual follow-up investigation and collecting peripheral blood samples for screening.
Detailed description
Patients will be recruited for 1 year and be follow-up for 3 years. Patients will make active hospital visit for collection of blood samples, which will be analyzed to develop a biosignature at the end of the study to detect very early hepatocellular carcinoma and stratify risk population for intensive follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis cohort | – | –Patients with liver cirrhosis. |
| HBV infection cohort | – | –Patients with seropositivity of HBsAg. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis cohort: patients with liver cirrhosis. HBV infection cohort: patients with chronic HBV infection.
Key inclusion criteria (15 listed)
- -
- [1] Cirrhosis cohort
- Age within 30 to 75 years.
- Diagnosis of liver cirrhosis within recent 6 months.
- <!-- -->
Key exclusion criteria (17 listed)
- [2] HBV infection cohort
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
Hepatocellular carcinoma
Time frame: July 2018 to July 2022
Development of hepatocellular carcinoma
Overall survival
Time frame: July 2018 to July 2022
Death
Liver-related disease progression
Time frame: July 2018 to July 2022
HBV and cirrhosis progression
1 secondary outcome
Non-hepatocellular carcinoma malignant neoplasm
Time frame: July 2018 to July 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Derived from this study: PubMed 38110372Xing X, Cai L, Ouyang J, Wang F, Li Z, Liu M, Wang Y, Zhou Y, Hu E, Huang C, Wu L, Liu J, Liu X. Proteomics-driven noninvasive screening of circulating serum protein panels for the early diagnosis of hepatocellular carcinoma. Nat Commun. 2023 Dec 18;14(1):8392. doi: 10.1038/s41467-023-44255-2.
- Individual participant dataSharing planned: Undecided
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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.
Hongyang Wang, MD and PhD principal investigator
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
Jinlin Hou, MD principal investigator
Nanfang Hospital, Southern Medical University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Eastern Hepatobiliary Surgery Hospital at 13 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 15 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 Hongyang Wang, PhD (86 21 81875361, hywangk@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatocellular carcinoma (time frame: July 2018 to July 2022). 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?
On the ClinicalTrials.gov record for NCT03588442, 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 22 May 2020.