AVIDA The Vidaza® (Azacitidine) Patient Registry

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Celgene Corporation.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00481273

First received: May 30, 2007

Last updated: February 22, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

February 22, 2010

Start Date ^ICMJE

October 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00481273 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

AVIDA The Vidaza® (Azacitidine) Patient Registry

Official Title ^ICMJE

AVIDA The Vidaza® (Azacitidine) Patient Registry

Brief Summary

This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Community-based hematology/oncology centers

Condition ^ICMJE

Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: Azacitidine

Physician's discretion

Other Name: Vidaza(R)

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

June 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment.
Patient who is able to read and speak English.
Patient who is willing and able to provide informed consent.
Patient who agrees to complete patient assessment questionnaires.

Exclusion Criteria:

Patients who are currently being treated with Vidaza®.
Patients who are concurrently participating in a clinical trial.
Patients unwilling or unable to complete the baseline and follow-up questionnaires.
Patients who are deemed inappropriate for treatment with Vidaza®.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00481273

Other Study ID Numbers ^ICMJE

AVIDA

Has Data Monitoring Committee

Responsible Party

Kristen Sullivan, Specialist, Disease Registry Projects, Celgene Corporation

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David L. Grinblatt, MD

NorthShore University HealthSystem Research Institute

Information Provided By

Celgene Corporation

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top