Trial record 1 of 118 for:
osteonecrosis
Osteonecrosis in Children With Acute Lymphoblastic Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Halton, Jacqueline, M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Halton, Jacqueline, M.D.
Collaborator:
C17 Council
Information provided by:
Halton, Jacqueline, M.D.
ClinicalTrials.gov Identifier:
NCT01104324
First received: April 12, 2010
Last updated: April 14, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Osteonecrosis Acute Lymphoblastic Leukemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Further study details as provided by Halton, Jacqueline, M.D.:
Primary Outcome Measures:
- osteonecrosis 1 year post leukemia therapy [ Time Frame: One year after completion of therapy for leukemia ] [ Designated as safety issue: No ]Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON
Secondary Outcome Measures:
- Bone mass density and Osteonecrosis [ Time Frame: One year post therapy for leukemia ] [ Designated as safety issue: No ]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
- Is Bone loss/failure to accure bone mineral and ON [ Time Frame: One year post leukemia therapy ] [ Designated as safety issue: No ]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
- Glucocorticoid dose and ON [ Time Frame: One year post Leukemia therapy ] [ Designated as safety issue: No ]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.
- Methotrexate dose and ON [ Time Frame: One year post leukemia therpy ] [ Designated as safety issue: No ]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.
- Obesity and ON [ Time Frame: One year post leukemia therapy ] [ Designated as safety issue: No ]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.
- Weight bearing and non weight bearing activities and ON [ Time Frame: One year post leukrmia therapy ] [ Designated as safety issue: No ]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.
- Hyperlipidemia and On [ Time Frame: One year post leukemia therapy ] [ Designated as safety issue: No ]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.
- Thrombophilia and ON [ Time Frame: One year post leukemia therapy ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Platlet free plasma
| Estimated Enrollment: | 130 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with Acute lymphoblastic leukemia who have participated in the STOPP - CIS study will be eligible for this ancillary study.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104324
Contacts
| Contact: Jacqueline Halton | 613 737 7600 ext 2978 | |
| Contact: Lynda Hoey | 613 737 7600 ext 4109 |
Locations
| Canada, Alberta | |
| Alberta Children's Hospital | Not yet recruiting |
| Calgary, Alberta, Canada | |
| Contact: Julie Hamilton 403 955 7641 | |
| Principal Investigator: Victor Lewis, MD | |
| Stollery Children's Hospital | Not yet recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Linda Churcher 780 407 8790 | |
| Principal Investigator: Bev Wilson, MD | |
| Canada, British Columbia | |
| BC Children's Hospital | Not yet recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Terry Viczko 604 875 2345 ext 5312 | |
| Principal Investigator: David Dix, MD | |
| Canada, Manitoba | |
| Winnipeg Children's Hospital | Not yet recruiting |
| Winnipeg, Manitoba, Canada | |
| Contact: Dan Catte 204 977 5645 | |
| Principal Investigator: Sara Israels, MD | |
| Canada, Nova Scotia | |
| IWK Health Centre | Not yet recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Alesha Warner 902 470-7414 | |
| Principal Investigator: Beth Cummings, MD | |
| Canada, Ontario | |
| Children's Hospital of Western Ontario | Not yet recruiting |
| London, Ontario, Canada | |
| Contact: Martha Rolland | |
| Principal Investigator: Beth Cairney, MD | |
| Childrens Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: , MacLennan 613 737 7600 | |
| Principal Investigator: Jacqueline Halton, MD | |
| Sub-Investigator: Leanne Ward, MD | |
| Hospital for Sick Children | Not yet recruiting |
| Toronto, Ontario, Canada | |
| Principal Investigator: Ron Grant | |
| Canada, Quebec | |
| Montreal Children's Hospital | Not yet recruiting |
| Montreal, Quebec, Canada | |
| Contact: Diane Laforte (514) 412-4400 ext 22521 | |
| Principal Investigator: Celia Rodd, MD | |
| Hopital Sainte-Justine | Not yet recruiting |
| Montreal, Quebec, Canada | |
| Contact: Claude Belleville (514) 345-4931 ext 2579 | |
| Principal Investigator: Nathalie Alos, MD | |
Sponsors and Collaborators
Halton, Jacqueline, M.D.
C17 Council
Investigators
| Principal Investigator: | Jacqueline Halton | Childrens Hospital of Easten Ontario |
More Information
No publications provided
| Responsible Party: | Jacqueline Halton MD, Childrens Hospital of Eastern Ontario |
| ClinicalTrials.gov Identifier: | NCT01104324 History of Changes |
| Other Study ID Numbers: | 08/20E |
| Study First Received: | April 12, 2010 |
| Last Updated: | April 14, 2010 |
| Health Authority: | Canada: CHEO Research Ethics Board |
Keywords provided by Halton, Jacqueline, M.D.:
|
bone health Osteonecrosis acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Osteonecrosis Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013