- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00719147
AVN of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone
Avascular Necrosis of Weight-Bearing Joints In Patients With Hematologic Malignancies Treated With Dexamethasone Or Prednisone
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Patients with acute lymphoblastic leukemia enrolled on the St. Jude Children's Research Hospital front-line Acuter Lymphoblastic Leukemia protocol, Total XIIIB or the front-line Non Hodgkin's Lymphoma protocol NHL13 from 11/94 to 6/98, in continuous complete remission or who have an MRI-confirmed diagnosis of AVN of the hip or knee prior to relapse are eligible for this study.
Patients will receive an MRI examination of the hips and knees based on the following:
- Patients who have no previous diagnosis of AVN and no previous MRI of the hips and knees will have a MRI of the hips and knees after the patient completes therapy.
- Patients who have no previous diagnosis of AVN and have had a previous MRI of the hips and knees after completion of therapy will need no further imaging. If the patient had not completed therapy at the time of the MRI, she/he will undergo MRI of hips and knees.
For patients with a previous AVN diagnosis and previous MRI of the hips and knees*, the first MRI which showed AVN will be used and plain radiographs of affected joints, if not already done, will be done.
*If a previous MRI showed AVN, but plain radiographs were not performed, the patient will have MRI and plain radiographs after enrollment in AVN2. If MRI of both hips and both knees with plain radiographs of affected joints have been done previously, the patient requires no further imaging but still will be enrolled on the study for the purpose of analysis.
- Patients who have a previous diagnosis of AVN and no previous MRI of the hips and knees will have a MRI evaluation of the hips and knees and plain radiographs of affected joints.
Patients will be referred to a bone doctor as needed.
Patients will be asked to fill out a questionnaire (which will take approximately 10 minutes) about any pain or problems that have with their hips and knees.
If patients have already agreed to take part in the PGEN4 or PGEN5 research study; studies researching how genes affect the way the body uses certain chemotherapy drugs, genetic information from the blood tests done as part of those studies will be used to see if it can be predicted who has the greatest risk of AVN.
All study tests will be done on one day.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Tennessee
-
Memphis, Tennessee, Verenigde Staten, 38105
- St. Jude Children's Research Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients with acute lymphoblastic leukemia enrolled on the SJCRH front-line ALL protocol, TOTAL XIIIB or the front-line NHL protocol NHL13 from 11/94 to 6/98.
- Patients must be in continuous complete remission or have an MRI-confirmed diagnosis of AVN of the hip or knee prior to relapse.
Exclusion Criteria:
-
Studie plan
Hoe is de studie opgezet?
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
1
|
Not performed for study purposes, MRI will be done as part of routine clinical visit.
Findings will be used for study.
Questionnaire
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
To compare the incidence of AVN in children with hematologic malignancies treated with prednisone versus dexamethasone during continuation
Tijdsspanne: 7-8 years
|
7-8 years
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Scott Howard, MD, St. Jude Children's Research Hospital
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Neoplasmata per site
- Hematologische ziekten
- Leukemie, Lymfoïde
- Leukemie
- Hematologische neoplasmata
- Voorlopercel lymfoblastische leukemie-lymfoom
- Necrose
Andere studie-ID-nummers
- AVN2
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .