LeukemiaNCT01207843
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias
An observational study of Leukemia and Infection, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- What is being tested?
- Imaging
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with suspected hepatolienal candidiasis.
Who may be able to join
- Chest and Abdomen CT with fungal lesion in patients with leukemia
Who cannot join
- Other liver pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verbesserung Der Radiologischen Diagnose Von Hepatolienaler Candidiasis während Der Therapie Der Leukämie
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.
- Being tested
- Imaging
- Keywords
- Computed tomography
- Medical subject headings
- Leukemia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingBehavioural
CT image validation and lesion measurement, as well as comparison of different CT phases
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Frauenfelder, MD, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207843
- Sponsor's protocol ID
- idr-3d-001
- Status last verified
- Aug 2014
- First submitted
- 21 Sep 2010
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbesserung Der Radiologischen Diagnose Von Hepatolienaler Candidiasis während Der Therapie Der Leukämie
- ClinicalTrials.gov ID
- NCT01207843
- Acronym / sponsor ID
- idr-3d-001
- Keywords
- Computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with suspected hepatolienal candidiasis.
Key inclusion criteria (1 listed)
- Chest and Abdomen CT with fungal lesion in patients with leukemia
Key exclusion criteria (1 listed)
- Other liver pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingCT image validation and lesion measurement, as well as comparison of different CT phases | Behavioural | – |
Primary outcome
The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Frauenfelder, MD principal investigator
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Infection, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.