NCT01518829

Brief Summary

the value of serum procalcitonin in differentiation between bacterial infection and non infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

January 24, 2012

Last Update Submit

September 29, 2013

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinompostablation syndromprocalcitonin

Outcome Measures

Primary Outcomes (1)

  • Differantiate between post- embolization syndrom and sepsis following locoregional treatment for hepatocellular carcinoma

    6months

Study Arms (2)

Patients with hepatocellular carcinoma

Patients with hepatocellular carcinoma who will undergo locoregional therapy

patients with chronic liver disease

patients with chronic liver disease, as a control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

inpatients in tropical medicine department and hepatocellular carcinoma out patient clinic ain shams university

You may qualify if:

  • \- Hepatocellular carcinoma patients who will undergo TACE and/or radio-frequency.
  • \- Fever more than 38C after 48 hours post intervention.

You may not qualify if:

  • HCC Patients who does not develop fever after intervention.
  • Proven infection elsewhere (e.g. UTI, chest infection..)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine department and hepatocellular carcinoma clinic

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Hisham K Dabbous, professor

    Tropical medicine department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical medicine ,Faculty of Medicine,Ain Shams university

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 26, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

EG(1)