Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003861|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment|
|Leukemia Acute Lymphoblastic Leukemia Acute Promyelocytic Leukemia||Other: laboratory biomarker analysis|
- To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome.
- To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome.
- To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features.
- To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.
|Study Type :||Observational|
|Estimated Enrollment :||840 participants|
|Official Title:||Molecular Genetic Features of Acute Leukemia|
|Study Start Date :||April 1999|
|Estimated Primary Completion Date :||January 2100|
Ancillary-Correlative (molecular genetic features)
Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.
|Other: laboratory biomarker analysis|
- Disease-free survival [ Time Frame: At baseline ]
- Overall survival [ Time Frame: At baseline ]
- Association of novel genes or micorRNAs with other biomarkers [ Time Frame: At baseline ]
- Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [ Time Frame: At baseline ]
- Clinical significance of MRD as defined by W T-1 [ Time Frame: At baseline ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003861
Show 51 Study Locations
|Study Chair:||Wendy Stock, MD||University of Chicago|