NCT05358496

Brief Summary

The aim of the study is to define the relationship between neutrophils, platelets and the activity of T lymphocytes in patients with NAFLD (nonalcoholic fatty liver disease). This study may predict, in the course of hepatic steatosis, specific phenotypic patterns expressed by PMNs and circulating platelets to evaluate their role in disease progression.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

September 29, 2021

Last Update Submit

April 27, 2022

Conditions

NAFLD- Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (5)

  • IL-8(interleukin 8)

    12 months

  • Morphology of Circulating Platelets in healthy donors, NAFL, and NASH patients wondering how they may drive and modulate the activity of T cells in this disease

    12 months

  • Platelets count in healthy donors, NAFL, and NASH patients

    12 months

  • number of Neutrophilis

    12 months

  • Morphology of Neutrophilis

    12 months

Study Arms (2)

NAFLD cohort

Diagnostic Test: Data collection

Validation cohort

Diagnostic Test: Data collection

Interventions

Data collectionDIAGNOSTIC_TEST

Clinical data collection

NAFLD cohortValidation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Italian caucasian patients over 18 years old with NAFLD diagnosis

You may qualify if:

  • Patients over 18
  • No alcoholic abuse
  • Hepatic steatosis diagnosticated by abdominal ultrasound
  • Negative hepatitis B and C tests
  • No history of hepatic cirrhosis

You may not qualify if:

  • Under 18
  • History of alcoholic abuse
  • Positive serology for hepatitis B or C
  • History of hepatic cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clara Balsano

L’Aquila, Italy/L'Aquila, 67100, Italy

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 29, 2021

First Posted

May 3, 2022

Study Start

May 3, 2021

Primary Completion

August 30, 2022

Study Completion

December 30, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations

IT(1)