Hematologic DiseaseNCT01178177
Radiologic Features of Invasive Pulmonary Aspergillosis
An observational study of Hematologic Disease and Solid Organ Transplantation, run by Asan Medical Center.
Trial summary
Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hematologic Disease, Solid Organ Transplantation
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Feb 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult patients who are diagnosed with invasive pulmonary aspergillosis (IPA)between January 2008 and February 2010.
Who may be able to join
- IPA cases with solid organ transplant recipients and hematologic disease patients
- proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria
Who cannot join
- under 16 years old
- possible cases of invasive pulmonary aspergillosis
About this study
Official title: Retrospective Analysis of Radiologic Features of Invasive Pulmonary Aspergillosis in Transplant Recipients and Neutropenic Patients.Transplant Recipients and Neutropenic Patients
Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.
- Conditions
- Hematologic Disease, Solid Organ Transplantation
- Keywords
- Invasive pulmonary aspergillosis, Solid organ transplantation, Hematologic disease
- Medical subject headings
- Hematologic Diseases, Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SOT recipients | solid organ transplant recipients with invasive pulmonary aspergillosis | |
| Hematologic disease | Hematologic disease patients with invasive pulmonary aspergillosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Han Kim, Asan Medical Center
- Investigators
- Sung-Han Kim, MD, Study chair, Department of Infectious Diseases, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178177
- Sponsor's protocol ID
- IPA -HEM vs SOT-2010
- Status last verified
- May 2013
- First submitted
- 9 Aug 2010
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SY, Lim C, Lee SO, Choi SH, Kim YS, Woo JH, Song JW, Kim MY, Chae EJ, Do KH, Song KS, Seo JB, Kim SH. Computed tomography findings in invasive pulmonary aspergillosis in non-neutropenic transplant recipients and neutropenic patients, and their prognostic value. J Infect. 2011 Dec;63(6):447-56. doi: 10.1016/j.jinf.2011.08.007. Epub 2011 Aug 16.
PubMed 21854805
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Radiologic Features of Invasive Pulmonary Aspergillosis in Transplant Recipients and Neutropenic Patients.Transplant Recipients and Neutropenic Patients
- ClinicalTrials.gov ID
- NCT01178177
- Acronym / sponsor ID
- IPA -HEM vs SOT-2010
- Conditions
- Hematologic Disease, Solid Organ Transplantation
- Keywords
- Invasive pulmonary aspergillosis, Solid organ transplantation, Hematologic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Aug 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.
Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOT recipients | – | –solid organ transplant recipients with invasive pulmonary aspergillosis |
| Hematologic disease | – | –Hematologic disease patients with invasive pulmonary aspergillosis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients who are diagnosed with invasive pulmonary aspergillosis (IPA)between January 2008 and February 2010.
Key inclusion criteria (2 listed)
- IPA cases with solid organ transplant recipients and hematologic disease patients
- proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria
Key exclusion criteria (2 listed)
- under 16 years old
- possible cases of invasive pulmonary aspergillosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 May 2013.
- Results publication: PubMed 21854805Park SY, Lim C, Lee SO, Choi SH, Kim YS, Woo JH, Song JW, Kim MY, Chae EJ, Do KH, Song KS, Seo JB, Kim SH. Computed tomography findings in invasive pulmonary aspergillosis in non-neutropenic transplant recipients and neutropenic patients, and their prognostic value. J Infect. 2011 Dec;63(6):447-56. doi: 10.1016/j.jinf.2011.08.007. Epub 2011 Aug 16.
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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.
Sung-Han Kim, MD study chair
Department of Infectious Diseases, Asan Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Disease and Solid Organ Transplantation, run by Asan Medical Center.
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 2 inclusion and 2 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 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178177, which also lists 1 linked publication.
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 16 May 2013.