AVIDA The Vidaza® (Azacitidine) Patient Registry

This study is currently recruiting participants.

Verified by Celgene Corporation, September 2008

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00481273

Purpose

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.

Condition	Intervention
Myelodysplastic Syndromes	Drug: Azacitidine

Drug Information available for: Azacitidine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	AVIDA The Vidaza® (Azacitidine) Patient Registry

Further study details as provided by Celgene Corporation:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2009

Intervention Details:

Physician's discretion

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Community-based hematology/oncology centers

Criteria

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®.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481273

Contacts

Contact: AVIDA Registry Help

866-461-8432

avidaregistry@celgene.com

Locations

United States, Missouri
AVIDA Registry Help	Recruiting
Kansas City, Missouri, United States, 66210
Contact 866-461-8432 avidaregistry@celgene.com

Sponsors and Collaborators

Celgene Corporation

Investigators

Principal Investigator:

David L. Grinblatt, MD

Evanston Northwestern Healthcare

More Information

Click here for more information about the registry This link exits the ClinicalTrials.gov site

Responsible Party:	Celgene Corporation ( Kristen Sullivan, Specialist, Disease Registry Projects )
Study ID Numbers:	AVIDA
Study First Received:	May 30, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00481273
Health Authority:	United States: Institutional Review Board

Keywords provided by Celgene Corporation:

MDS

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Azacitidine
Bone Marrow Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009