Natural History Study of Patients With Chronic Myelogenous Leukemia
Chronic Myeloid Leukemia (CML) Cohort
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Impact of current procedures for diagnosis, management, and follow-up on disease status
Tidsramme: 5 years
|
5 years
|
|
Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate
Tidsramme: 5 years
|
5 years
|
|
Health perceptions, symptoms, insurance issues, and work issues
Tidsramme: 5 years
|
5 years
|
|
Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness
Tidsramme: 5 years
|
5 years
|
|
Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate
Tidsramme: 5 years
|
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Jerome Ritz, MD, Dana-Farber Cancer Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 03-015
- P30CA006516 (U.S. NIH-bevilling/kontrakt)
- CDR0000352370
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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