Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429910
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2007-01-30
Brief Title:
Natural History Study of Patients With Chronic Myelogenous Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Chronic Myeloid Leukemia CML Cohort
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care
PURPOSE This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia
PURPOSE This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the impact of current procedures for diagnosis management and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia CML
Determine the natural history of patients with CML who achieve response to imatinib mesylate
Determine the health perceptions symptoms insurance issues and work issues of these patients
Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients
Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients
OUTLINE This is a longitudinal prospective cohort study
Patients complete quality of life functional status medical and treatment history and medication questionnaires at baseline and then every 6 months for 5 years
Blood samples are collected at baseline and then every 6 months for 5 years Specimens may be examined in the future in gene array studies and mutation analyses
Determine the impact of current procedures for diagnosis management and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia CML
Determine the natural history of patients with CML who achieve response to imatinib mesylate
Determine the health perceptions symptoms insurance issues and work issues of these patients
Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients
Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients
OUTLINE This is a longitudinal prospective cohort study
Patients complete quality of life functional status medical and treatment history and medication questionnaires at baseline and then every 6 months for 5 years
Blood samples are collected at baseline and then every 6 months for 5 years Specimens may be examined in the future in gene array studies and mutation analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000352370 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |