Hematological DiseasesNCT00838643
Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
An observational study of Hematological Diseases and Invasive Aspergillosis, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
Trial summary
Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hematological Diseases, Invasive Aspergillosis
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- May 2002to Dec 2009
- 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: Adult patients given allogeneic HSCT in tertiary care centers or university hospitals in Piedmont
Who may be able to join
- Age > 16 years
- Allogeneic HSCT for a haematological disease
- Written informed consent to the study
Who cannot join
- Pediatric patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Invasive Aspergillosis in Allogeneic Stem Cell Transplantation Patients: an Italian Prospective Multicentre Study
Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.
- Conditions
- Hematological Diseases, Invasive Aspergillosis
- Keywords
- allogeneic transplantation, Invasive aspergillosis
- Medical subject headings
- Hematologic Diseases
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 |
|---|---|---|
| Allogeneic pts | Adult allogeneic HSCT recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of invasive aspergillosis
Measured: 1 year
Secondary outcomes (1)
Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startMay 2002
- Primary completionJun 2007
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseasesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838643
- Sponsor's protocol ID
- Gal-01
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Invasive Aspergillosis in Allogeneic Stem Cell Transplantation Patients: an Italian Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT00838643
- Acronym / sponsor ID
- Gal-01
- Conditions
- Hematological Diseases, Invasive Aspergillosis
- Keywords
- allogeneic transplantation, Invasive aspergillosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Feb 2009 (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.
Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic pts | – | –Adult allogeneic HSCT recipients |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients given allogeneic HSCT in tertiary care centers or university hospitals in Piedmont
Key inclusion criteria (3 listed)
- Age > 16 years
- Allogeneic HSCT for a haematological disease
- Written informed consent to the study
Key exclusion criteria (1 listed)
- Pediatric patients
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
Incidence of invasive aspergillosis
Time frame: 1 year
1 secondary outcome
Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases and Invasive Aspergillosis, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
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 3 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 9 Feb 2009. 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 Italy. 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?
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?
Incidence of invasive aspergillosis (time frame: 1 year). 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 9 Feb 2009.