Recruiting

Observational Study

Sponsor:

Halton, Jacqueline, M.D.

Code:

NCT01104324

Conditions

Osteonecrosis

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Osteonecrosis

Acute Lymphoblastic Leukemia

Study ID

NCT01104324

Start date

Jul, 2009

Status verified date

Apr, 2010

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • osteonecrosis 1 year post leukemia therapy [ Time Frame: One year after completion of therapy for leukemia ]

Central Contacts and Locations

Central contacts

Jacqueline Halton

613 737 7600

Lynda Hoey

613 737 7600

Locations

Childrens Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada

Contacts

MacLennan

613 737 7600

Principal Investigator:

Jacqueline Halton, MD

More Information

Sponsor

Halton, Jacqueline, M.D.

Last update posted

Apr 15, 2010

Last verified

Apr, 2010

Keywords

  • bone health
  • Osteonecrosis
  • acute lymphoblastic leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Halton, Jacqueline, M.D. on 2010-04-15.