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Status unknownNCT03588442PRECARUpdated May 22, 2020

Prospective Surveillance for Very Early Hepatocellular Carcinoma

An observational study in Carcinoma, Hepatocellular, sponsored by Eastern Hepatobiliary Surgery Hospital. Status unknown at 13 sites in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
30 Years to 75 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Carcinoma, Hepatocellular
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In context

Carcinoma, Hepatocellular

3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 69 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cirrhosis cohort: patients with liver cirrhosis. HBV infection cohort: patients with chronic HBV infection.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

[1] Cirrhosis cohort

  1. Age within 30 to 75 years.
  2. Diagnosis of liver cirrhosis within recent 6 months.

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  1. Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6.
  2. No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage.

  3. 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

      1. Age within 40 to 70 years
      2. Chronic HBV infection (seropositive for HBsAg over 6 months).

Exclusion criteria

Exclusion Criteria:

  1. Cirrhosis cohort

(1) Child-Pugh score of C.

(2) Hereditary metabolic liver diseases.

(3) Presence of HIV-Ab.

(4) Previous diagnosis of active pulmonary tuberculosis.

(5) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.

(6) Patients who had received allogeneic blood transfusion or cell therapy within 1 year.

(7) Pregnant women.

[2] HBV infection cohort

(1) Autoimmune liver diseases.

(2) Hereditary metabolic liver diseases.

(3) Other chronic liver diseases, such as flukes.

(4) Presence of HCV, HDV, HEV, or HIV infection.

(5) Previous diagnosis of active pulmonary tuberculosis.

(6) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.

(7) Patients who had received allogeneic blood transfusion or cell therapy within 1 year.

(8) Pregnant women.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cirrhosis cohort

    Patients with liver cirrhosis.

  • HBV infection cohort

    Patients with seropositivity of HBsAg.

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What researchers measure

Primary outcomes

  1. Hepatocellular carcinoma

    Development of hepatocellular carcinoma

    Time frame: July 2018 to July 2022

  2. Overall survival

    Death

    Time frame: July 2018 to July 2022

  3. Liver-related disease progression

    HBV and cirrhosis progression

    Time frame: July 2018 to July 2022

Secondary outcomes

  1. Non-hepatocellular carcinoma malignant neoplasm

    Development of other primary liver cancer, such as Intrahepatic cholangiocarcinoma.

    Time frame: July 2018 to July 2022

07

Study locations

13 of 13 sites recruiting
  • The First Hospital Affiliated to AMU (Southwest Hospital)
    Chongqing, Chongqing Municipality 400038, China
    Recruiting
  • Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University
    Fuzhou, Fujian 350025, China
    Recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    Recruiting
  • The Central Hospital of Wuhan
    Wuhan, Hubei 430014, China
    Recruiting
  • Chifeng Municipal Hospital
    Chifeng, Inner Mongolia 024000, China
    Recruiting
  • Xuzhou No.1 People's Hospital
    Xuzhou, Jiangsu 221002, China
    Recruiting
  • Xuzhou Infectious Disease Hospital
    Xuzhou, Jiangsu 221004, China
    Recruiting
  • The First Bethune of Jilin University
    Changchun, Jilin 130021, China
    Recruiting
  • The Second Hospital of Shandong University
    Jinan, Shandong 250000, China
    Recruiting
  • Shanghai Public Health Clinical Center
    Shanghai, Shanghai Municipality 200000, China
    Recruiting
  • Shanghai Oriental Hepatobiliary Surgery Hospital
    Shanghai, Shanghai Municipality 200438, China
    Recruiting
  • First Affiliated Hospital, Xinjiang Medical University
    Ürümqi, Xinjiang 830054, China
    Recruiting
  • HwaMei Hospital, University of Chinese Academy of Sciences
    Ningbo, Zhejiang 315000, China
    Recruiting
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References and documents

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 documents

  • Protocol and statistical analysis plan · Apr 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2018 (actual). Primary completion is estimated for Jul 2022, 48 months after the start.

Of 273 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 112. This study's planned 48 months is close to that.

Counting every sponsor, half of 313 studies reached it within 50 months; a quarter within 32 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2018
First posted
Jul 17, 2018
StartActual
Jul 15, 2018
Primary completionEst.
Jul 15, 2022
CompletionEst.
Jul 15, 2023
Last update
May 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03588442
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
Lei Chen, PhD (Professor, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Jul 17, 2018
Start date
Jul 15, 2018
Primary completion
Jul 15, 2022 (estimated)
Completion
Jul 15, 2023 (estimated)
Last update
May 22, 2020

Study contacts

Hongyang Wang, PhD
Contact
hywangk@vip.sina.com
86 21 81875361
Lei Chen, PhD
Contact
chenlei@smmu.edu.cn
86 13918939969
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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