NCT01395628

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial is studying samples from patients with leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 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

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.8 years

First QC Date

July 14, 2011

Last Update Submit

May 17, 2016

Conditions

Keywords

chronic phase chronic myelogenous leukemiachildhood acute promyelocytic leukemia (M3)childhood acute myeloid leukemia/other myeloid malignanciesadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with del(5q)adult acute promyelocytic leukemia (M3)

Outcome Measures

Primary Outcomes (3)

  • Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo

  • In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells

  • Effects of novel anticancer drugs and/or their combinations on individual samples

Interventions

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with myeloid disease.

DISEASE CHARACTERISTICS: * Samples of blood and tissue cells from patients diagnosed with myeloid disease including the following subtypes: * Chronic phase chronic myeloid leukemia (CML), to complement initial studies in the K562 CML cell line * Acute promyelocytic leukemia (APL), to complement initial studies in the NB4 APL cell line * Acute myeloid leukemia (AML) expressing the t(8;21)(q22;q22) translocation, which occurs in approximately 12% of pediatric AML and is associated with good prognosis * AML expressing 5q- or monosomy 7, associated with a poor prognosis * AML expressing the fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), associated with a poor prognosis 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

Biospecimen

Retention: SAMPLES WITH DNA

cell samples

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Promyelocytic, Acute

Interventions

Flow CytometryMicroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myeloid, Acute

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesDiagnostic Imaging

Study Officials

  • Jason N. Berman, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 15, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05