CancerNCT00445952
Natural History Study of Fungal Infections of the Blood in Patients With Cancer or in Patients Who Have Undergone a Stem Cell Transplant
An observational study of Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 5 sites in 5 countries.
Trial summary
RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- clinical observation and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 304 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Feb 2005to 12 May 2016
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Group A:
- Meets any of the following criteria:
- Diagnosis of hematological malignancy including, but not limited to, any of the following:
- Acute lymphoblastic leukemia
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Chronic lymphocytic leukemia
- Diagnosis of solid tumor, including, but not limited to, any of the following:
- Breast cancer (hormone receptor status not specified)
- Lung cancer
- Colon cancer
- Recipient of a hematopoietic stem cell transplantation, including, but not limited to, any of the following:
- Allogeneic or autologous bone marrow transplantation
- Peripheral blood stem cell transplantation
- Admitted to a participating hospital ward (defined as ≥ 1 overnight stay)
- Group B:
- Meets the same criteria as in group A
- Positive blood culture for a fungus
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior participation in this study
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Switzerland1 site
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
About this study
Official title: Fungemia Survey in Cancer Patients
RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.
PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.
Read the detailed description
OBJECTIVES:
- Determine the incidence of fungemia in relation to the number of admissions to the hospital in patients with solid tumor or hematologic malignancy or in patients who have undergone hematopoietic stem cell transplantation.
- Determine the fungal species distribution, prognostic factors for outcome, and crude and attributable mortality in patients also diagnosed with fungemia.
OUTLINE: This is a multicenter, nonrandomized, prospective study.
- Group A (no documented fungemia at study entry): Data regarding the number of patients with cancer or who have undergone hematopoietic stem cell transplantation, including those who develop documented fungemia, who are admitted to the hospital is collected for 2 years.
- Group B (documented fungemia at study entry): Fungal strains isolated from the initial positive blood culture are collected and undergo examination, including confirmation of species identification, susceptibility testing, and/or minimum inhibitory concentration determination. Data, including antifungal treatment, clinical and microbiological response to antifungal treatment (at 2, 4, and 12 weeks after diagnosis), and survival status, is collected for each documented fungemia episode* for up to 12 weeks after diagnosis of fungemia.
NOTE: *That occurs within a 2-year period.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
- Conditions
- Cancer
- Being tested
- clinical observation, management of therapy complications
- Keywords
- breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, male breast cancer, recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer
- Medical subject headings
- Neoplasms, Breast Carcinoma In Situ, Breast Neoplasms, Breast Neoplasms, Male, Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Congenital Abnormalities, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical observationOther
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative incidence of fungemia
Fungal species distribution
Survival in patients with fungemia
Mortality at 2, 4, and 12 weeks after diagnosis of fungemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startFeb 2005
- Primary completionNov 2009
- Study completion12 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Oliver Cornely, Study chair, German Hodgkin's Lymphoma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445952
- Sponsor's protocol ID
- EORTC-65031
- Other IDs
- EORTC-65031
- Status last verified
- Jan 2018
- First submitted
- 7 Mar 2007
- Last updated
- 1 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungemia Survey in Cancer Patients
- ClinicalTrials.gov ID
- NCT00445952
- Acronym / sponsor ID
- EORTC-65031
- Conditions
- Cancer
- Keywords
- breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 9 Mar 2007 (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.
RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.
PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.
Detailed description
OBJECTIVES:
- Determine the incidence of fungemia in relation to the number of admissions to the hospital in patients with solid tumor or hematologic malignancy or in patients who have undergone hematopoietic stem cell transplantation.
- Determine the fungal species distribution, prognostic factors for outcome, and crude and attributable mortality in patients also diagnosed with fungemia.
OUTLINE: This is a multicenter, nonrandomized, prospective study.
- Group A (no documented fungemia at study entry): Data regarding the number of patients with cancer or who have undergone hematopoietic stem cell transplantation, including those who develop documented fungemia, who are admitted to the hospital is collected for 2 years.
- Group B (documented fungemia at study entry): Fungal strains isolated from the initial positive blood culture are collected and undergo examination, including confirmation of species identification, susceptibility testing, and/or minimum inhibitory concentration determination. Data, including antifungal treatment, clinical and microbiological response to antifungal treatment (at 2, 4, and 12 weeks after diagnosis), and survival status, is collected for each documented fungemia episode* for up to 12 weeks after diagnosis of fungemia.
NOTE: *That occurs within a 2-year period.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| clinical observation | Other | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Relative incidence of fungemia
Fungal species distribution
Survival in patients with fungemia
Mortality at 2, 4, and 12 weeks after diagnosis of fungemia
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 1 Feb 2018.
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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.
Oliver Cornely study chair
German Hodgkin's Lymphoma Study Group
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, France, Germany, Italy, 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?
Relative incidence of fungemia. The study lists 4 primary outcomes in all. 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 1 Feb 2018.