NCT01207843

Brief Summary

Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis. The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Typical duration 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

Study Start

First participant enrolled

October 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

September 21, 2010

Last Update Submit

August 18, 2014

Conditions

LeukemiaInfection

Keywords

Computed tomography

Outcome Measures

Primary Outcomes (1)

  • The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia

    2 Years

Interventions

ImagingBEHAVIORAL

CT image validation and lesion measurement, as well as comparison of different CT phases

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with suspected hepatolienal candidiasis.

You may qualify if:

  • Chest and Abdomen CT with fungal lesion in patients with leukemia

You may not qualify if:

  • Other liver pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

LeukemiaInfections

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Thomas Frauenfelder, MD

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 23, 2010

Study Start

October 1, 2009

Primary Completion

April 1, 2011

Study Completion

May 1, 2013

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

CH(1)