Hematological DiseaseNCT01684189
Registry of Febrile Neutropenia and Invasive Fungal Infections
An observational study of Hematological Disease and Febrile Neutropenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Objectives： 1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy 2. To explore the percentage/distribution of infectious origins of febrile neutropenia 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematological Disease, Febrile Neutropenia, Fungal Infections
- What is being tested?
- Patient registry
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2011to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed malignant hematological diseases
Who may be able to join
- Patients with new diagnosed hematological diseases (acute and chronic myeloid and lymphoid leukemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, myelodysplastic syndromes)
- Patients who are receiving chemotherapy and have ongoing febrile episodes
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Ming-Chung Wang, M.D., +886-7-7317123 ext. 3266, wang9595@ms32.hinet.net
Ming-Chung Wang, M.D.
About this study
Official title: A Non-interventional Prospective Registry to Monitor the Events of Febrile Neutropenia and Invasive Fungal Infections and the Diagnostic and Therapeutic Management in Patients With Malignant Hematologic Diseases After Chemotherapy
Objectives：
- To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
- To explore the percentage/distribution of infectious origins of febrile neutropenia
- To explore the percentage/distribution of infectious pathogens of febrile neutropenia
- To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
- To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Read the detailed description
Objectives：
- To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
- To explore the percentage/distribution of infectious origins of febrile neutropenia
- To explore the percentage/distribution of infectious pathogens of febrile neutropenia
- To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
- To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Study Design：
- This is a single institute, prospective, non-interventional registry for monitoring events of febrile neutropenia in hematological patients
- Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry
Study Procedures： Data collection will include patients' basic information, underlying disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up, clinical response, microbiology (including bacteria and fungus culture), renal and liver function, clinical diagnosis, work-up and intensive procedures and results, antifungal and antibacterial agents (including dosage, duration, and route), other drugs used (including antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes
Sample Size Calculation and Statistical Analysis： Approximately 100 febrile neutropenia episodes in 500 chemotherapy cycles will be collected. This is an observational and exploratory study without hypothesis tests. Study subjects will be collected and monitored under normal clinical practice, and the sample size will be limited due to the hospital scale and disease characteristic (the sample size calculation is inapplicable here). All evaluations will be shown by exploratory and descriptive data analysis. The number of cases for each investigative definition, the corresponding percentage and the 95% confidence interval will be described.
- Being tested
- Patient registry
- Medical subject headings
- Hematologic Diseases, Febrile Neutropenia, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient registryOther
Patient registry without study intervention
| Study group | Role | What they receive |
|---|---|---|
| Patient registry | Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry Receives: Other: Patient registry |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startNov 2011
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Chung Wang, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684189
- Sponsor's protocol ID
- MISP38887
- Status last verified
- Nov 2011
- First submitted
- 10 Sep 2012
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Prospective Registry to Monitor the Events of Febrile Neutropenia and Invasive Fungal Infections and the Diagnostic and Therapeutic Management in Patients With Malignant Hematologic Diseases After Chemotherapy
- ClinicalTrials.gov ID
- NCT01684189
- Acronym / sponsor ID
- MISP38887
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Study completion
- Aug 2013 (estimated)
- First posted
- 12 Sep 2012 (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.
Objectives：
- To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
- To explore the percentage/distribution of infectious origins of febrile neutropenia
- To explore the percentage/distribution of infectious pathogens of febrile neutropenia
- To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
- To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Detailed description
Objectives：
- To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
- To explore the percentage/distribution of infectious origins of febrile neutropenia
- To explore the percentage/distribution of infectious pathogens of febrile neutropenia
- To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
- To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Study Design：
- This is a single institute, prospective, non-interventional registry for monitoring events of febrile neutropenia in hematological patients
- Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry
Study Procedures： Data collection will include patients' basic information, underlying disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up, clinical response, microbiology (including bacteria and fungus culture), renal and liver function, clinical diagnosis, work-up and intensive procedures and results, antifungal and antibacterial agents (including dosage, duration, and route), other drugs used (including antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes
Sample Size Calculation and Statistical Analysis： Approximately 100 febrile neutropenia episodes in 500 chemotherapy cycles will be collected. This is an observational and exploratory study without hypothesis tests. Study subjects will be collected and monitored under normal clinical practice, and the sample size will be limited due to the hospital scale and disease characteristic (the sample size calculation is inapplicable here). All evaluations will be shown by exploratory and descriptive data analysis. The number of cases for each investigative definition, the corresponding percentage and the 95% confidence interval will be described.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient registry | – | Other: Patient registryPatients with newly diagnosed malignant hematological diseases will be enrolled into this registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed malignant hematological diseases
Key inclusion criteria (2 listed)
- Patients with new diagnosed hematological diseases (acute and chronic myeloid and lymphoid leukemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, myelodysplastic syndromes)
- Patients who are receiving chemotherapy and have ongoing febrile episodes
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Patient registryPatient registry without study intervention | Other | Patient registry |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
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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.
Ming-Chung Wang, M.D. principal investigator
Chang Gung Memorial Hospital
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 Hematological Disease and Febrile Neutropenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 12 Sep 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Chung Wang, M.D. (+886-7-7317123 ext. 3266, wang9595@ms32.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Sep 2012.