NCT01104324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 15, 2010

Status Verified

April 1, 2010

Enrollment Period

3.4 years

First QC Date

April 12, 2010

Last Update Submit

April 14, 2010

Conditions

OsteonecrosisAcute Lymphoblastic Leukemia

Keywords

bone healthOsteonecrosisacute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Bone mass density and Osteonecrosis

    One year post therapy for leukemia

  • Is Bone loss/failure to accure bone mineral and ON

    One year post leukemia therapy

  • Glucocorticoid dose and ON

    One year post Leukemia therapy

  • Methotrexate dose and ON

    One year post leukemia therpy

  • Obesity and ON

    One year post leukemia therapy

  • +3 more secondary outcomes

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Acute lymphoblastic leukemia who have participated in the STOPP - CIS study will be eligible for this ancillary study.

You may qualify if:

  • Enrollment in the STOPP-CIS study
  • Informed consent of patient or care givers
  • \>5 years of age at MRI assessment

You may not qualify if:

  • Individuals with a history of claustrophobia precluding MRI assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Alberta Children's Hospital

Calgary, Alberta, Canada

NOT YET RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

NOT YET RECRUITING

BC Children's Hospital

Vancouver, British Columbia, Canada

NOT YET RECRUITING

Winnipeg Children's Hospital

Winnipeg, Manitoba, Canada

NOT YET RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

NOT YET RECRUITING

Children's Hospital of Western Ontario

London, Ontario, Canada

NOT YET RECRUITING

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, Canada

RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

NOT YET RECRUITING

Hopital Sainte-Justine

Montreal, Quebec, Canada

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Platlet free plasma

MeSH Terms

Conditions

OsteonecrosisPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jacqueline Halton

    Childrens Hospital of Easten Ontario

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Halton

CONTACT

613 737 7600

Lynda Hoey

CONTACT

613 737 7600

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 15, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 15, 2010

Record last verified: 2010-04

Locations

CA(10)