NCT00899899

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. PURPOSE: This laboratory study is looking at resistance to methotrexate in patients with acute lymphoblastic leukemia in relapse or remission.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1998

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
3.1 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
Last Updated

September 30, 2015

Status Verified

May 1, 2015

Enrollment Period

6.8 years

First QC Date

May 9, 2009

Last Update Submit

September 28, 2015

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiarecurrent childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (3)

  • Mechanisms of intrinsic and acquired methotrexate resistance

  • Correlation of acquired methotrexate resistance with dosage or timing of methotrexate administration

  • Correlation of acquired methotrexate resistance with other clinical factors

Interventions

microarray analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute lymphoblastic leukemia (ALL) in relapse

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Acute lymphoblastic leukemia (ALL) in relapse, including all risk groups and leukemia subtypes, with frozen leukemic blast samples stored from the time of initial diagnosis and relapse * Non-relapsing ALL (as control) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Microarray AnalysisReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

  • Richard Gorlick, MD

    Children's Hospital at Montefiore

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 1, 1998

Primary Completion

March 1, 2005

Study Completion

April 1, 2006

Last Updated

September 30, 2015

Record last verified: 2015-05