NCT00838643

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

5.1 years

First QC Date

February 5, 2009

Last Update Submit

February 6, 2009

Conditions

Hematological DiseasesInvasive Aspergillosis

Keywords

allogeneic transplantationInvasive aspergillosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of invasive aspergillosis

    1 year

Secondary Outcomes (1)

  • Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial

    1 year

Study Arms (1)

Allogeneic pts

Adult allogeneic HSCT recipients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients given allogeneic HSCT in tertiary care centers or university hospitals in Piedmont

You may qualify if:

  • Age \> 16 years
  • Allogeneic HSCT for a haematological disease
  • Written informed consent to the study

You may not qualify if:

  • Pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Ospedaliera santa Croce e Carle

Cuneo, 12100, Italy

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

May 1, 2002

Primary Completion

June 1, 2007

Study Completion

December 1, 2009

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

IT(1)