NCT00898469

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to bone tissue death. PURPOSE: This laboratory study is looking at risk factors for bone tissue death in young patients with acute lymphoblastic leukemia treated on clinical trial CCG-1882.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
671

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Status
completed

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

March 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

11.2 years

First QC Date

May 9, 2009

Last Update Submit

May 9, 2016

Conditions

Keywords

childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

  • Identification of possible pharmacogenetic risk factors for avascular necrosis

    length of study

  • Comparison of whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin D receptor C/C start site genotype are more common among patients who developed avascular necrosis than among patients who did not

    length of study

Interventions

Eligibility Criteria

Age10 Years - 120 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients who received intensive therapy for acute lymphoblastic leukemia on clinical trial CCG-1882.

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * Has diagnostic ALL blast sample slides available for DNA extraction * Previously treated on clinical trial CCG-1882 PATIENT CHARACTERISTICS: Age * 10 and over at diagnosis Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Hamilton LH, Mattano LA, Sather HN, et al.: A SERPINE1 (PAI-1) single nucleotide polymorphism predicts osteonecrosis in children treated for acute lymphoblastic leukemia: results of the Childrens Oncology Group (COG) study AALL03B2. [Abstract] Blood 108 (11): A-709, 2006.

    RESULT

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Mary Relling, PharmD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

March 1, 2005

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05