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Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT02335073
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Xingshun Qi, General Hospital of Shenyang Military Region

Brief Summary:
Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.

Condition or disease Intervention/treatment
Liver Cirrhosis Other: Venous blood

Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Observational Study
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis




Primary Outcome Measures :
  1. Death [ Time Frame: 6-12 months ]

Secondary Outcome Measures :
  1. Hepatic decompensation events [ Time Frame: 6-12 months ]

Biospecimen Retention:   None Retained
Venous blood


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population should be patients with a diagnosis of liver cirrhosis who were admitted to the Department of Gastroenterology of the General Hospital of Shenyang Military Area.
Criteria

Inclusion Criteria:

  1. Patients were admitted to our department.
  2. Patients were diagnosed with liver cirrhosis.
  3. Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA).

Exclusion Criteria:

  1. Non-cirrhotic patients.
  2. Malignancy.
  3. Severe cardiopulmonary diseases.
  4. Severe infectious diseases.
  5. Other diseases with a shortened lifespan.
  6. Pregnant and breastfeeding.
  7. Poor adherence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335073


Locations
China, Liaoning
Department of Gastroenterology, General Hospital of Shenyang Military Area
Shenyang, Liaoning, China, 110840
Sponsors and Collaborators
General Hospital of Shenyang Military Region

Responsible Party: Xingshun Qi, Dr., General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT02335073     History of Changes
Other Study ID Numbers: LFT4-LC
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xingshun Qi, General Hospital of Shenyang Military Region:
Prognosis

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases