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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01104324
Other study ID # 08/20E
Secondary ID
Status Recruiting
Phase N/A
First received April 12, 2010
Last updated April 14, 2010
Start date July 2009
Est. completion date December 2012

Study information

Verified date April 2010
Source Halton, Jacqueline, M.D.
Contact Jacqueline Halton
Phone 613 737 7600
Is FDA regulated No
Health authority Canada: CHEO Research Ethics Board
Study type Observational

Clinical Trial Summary

Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- Enrollment in the STOPP-CIS study

- Informed consent of patient or care givers

- >5 years of age at MRI assessment

Exclusion Criteria:

- Individuals with a history of claustrophobia precluding MRI assessment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada Stollery Children's Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada Children's Hospital of Western Ontario London Ontario
Canada Hopital Sainte-Justine Montreal Quebec
Canada Montreal Children's Hospital Montreal Quebec
Canada Childrens Hospital of Eastern Ontario Ottawa Ontario
Canada Hospital for Sick Children Toronto Ontario
Canada BC Children's Hospital Vancouver British Columbia
Canada Winnipeg Children's Hospital Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
Halton, Jacqueline, M.D. C17 Council

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary osteonecrosis 1 year post leukemia therapy Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON One year after completion of therapy for leukemia No
Secondary Bone mass density and Osteonecrosis Is reductions in bone mass density at diagnosis of leukemia associated with the development of ON. These patients are a subset of a lagre study where Bone mass is being measured by DEXA. We will be able to access this data to look for bone mass density One year post therapy for leukemia No
Secondary Is Bone loss/failure to accure bone mineral and ON Is bone loss/failure to accrue bone mineral at a normal rate during chemotherapy is/are associated with the development of ON.These patients are a subset of a lagre study where Bone mass is being measured by DEXA. We will be able to access this data to look for bone loss One year post leukemia therapy No
Secondary Glucocorticoid dose and ON Is there a glucocorticoid threshold dose, above which patients are more likely to develop ON. These patients are a subset of a lagre study where glucocorticoid dose is recorded. We will be able to access this data. One year post Leukemia therapy No
Secondary Methotrexate dose and ON Is there a methotrexate threshold dose, above which patients are more likely to develop ON. These patients are a subset of a lagre study where Methotrexate dose is recorded. We will be able to access this data. One year post leukemia therpy No
Secondary Obesity and ON Is obesity either at diagnosis or during therapy associated with ON. These patients are a subset of a larger group in a larger study. They are recording height weight and BMI. We will be able to access this data. One year post leukemia therapy No
Secondary Weight bearing and non weight bearing activities and ON Does weight bearing and non-weight bearing activities play a role in the development of ON. These patients are a subset of a larger study. They are recording these activities. We will be able to use this data. One year post leukrmia therapy No
Secondary Hyperlipidemia and On Is hyperlipidemia associated with the development of ON. Statins (cholesterol lowering medications) have been suggested as a therapeutic intervention to prevent ON. Fasting blood will be tested for lipids at at least one year post chemtherapy. One year post leukemia therapy No
Secondary Thrombophilia and ON Is thrombophilia associated with the development of ON. Blood will be tested at study entry following one year completion of chemotherapy.Blood will be drawn for protein C, protein S, antithrombin, activated protein C resistance, Factor V Leiden, prothrombin gene complex, MTHFR, lupus anticoagulant and antiphospholipid antibodies and Lipoprotein A. One year post leukemia therapy No
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