Invasive Aspergillosis After Allogeneic Hematopoietic Ste... | NCT00838643

Studies
Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

NCT00838643

Sponsor

Ospedale Santa Croce-Carle Cuneo

Status

Unknown status

Last Update Posted

Feb 9, 2009Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Hematological Diseases
Invasive Aspergillosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Jun 2007Actual

Completion Date

Dec 2009Estimated

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2009

Last Update Posted Date

Feb 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Label	Type	Description	Intervention Names
Allogeneic pts		Adult allogeneic HSCT recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of invasive aspergillosis		1 year

Secondary Outcomes

Measure	Description	Time Frame
Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pediatric patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Sanitaria Ospedaliera santa Croce e Carle		Cuneo		12100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006402	Hematologic Diseases

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided