Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
Summary
RATIONALE: Determination of genetic markers for acute lymphoblastic leukemia and acute promyelocytic leukemia may help identify patients with this disease and help predict the outcome of treatment.
PURPOSE: Diagnostic study of genetic markers in adult patients who have acute lymphoblastic leukemia or acute promyelocytic leukemia.
Description
OBJECTIVES:
- Perform quantitative polymerase chain reaction (PCR) using known leukemia specific markers in diagnostic bone marrow specimens and correlate pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcomes of patients with previously untreated acute lymphoblastic leukemia (ALL) or acute promyelocytic leukemia (APL).
- Evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of these patients and correlate these findings with other biological features and treatment outcome.
- Evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment and correlate these findings with efficacy of novel treatment approaches and other biological and clinical prognostic features.
- Compare the measurement of MRD in blood with bone marrow specimens in sequential remission specimens.
OUTLINE: Blood and bone marrow samples are collected from patients periodically.
Samples are examined for the p190 and p210 BCR-ABL and WT-1 transcripts using reverse transcriptase-polymerase chain reaction (RT-PCR) analysis of the DNA and for marginal residual disease (MRD) via flow cytometric analysis.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study over 5 years.
Study Design
Primary Purpose: Diagnostic
Conditions
Leukemia
Intervention
reverse transcriptase-polymerase chain reaction, flow cytometry
Location
Naval Medical Center - San Diego
San Diego
California
United States
92134
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00003861
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:58:28-0400
Clinical Trials
Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This laboratory study is look...
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard fo...
Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia
RATIONALE: Studying samples of tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to c...
The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as comp...
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may ...
PubMed Articles
Reverse Transcription Polymerase Chain Reaction in Giant Unilamellar Vesicles.
We assessed the applicability of giant unilamellar vesicles (GUVs) for RNA detection using in vesicle reverse transcription polymerase chain reaction (RT-PCR). We prepared GUVs that encapsulated one-p...
Human telomerase reverse transcriptase (TERT) is the catalytic subunit of telomerase, and it elongates telomere through RNA-dependent DNA polymerase activity. Although TERT is named as a reverse trans...
Emerging utility of flow cytometry in the diagnosis of chronic myelomonocytic leukemia.
The diagnosis of many hematologic malignancies has shifted from being based almost exclusively on morphology and clinical data to include ancillary studies such as flow cytometry. This trend has yet t...
Identification of the UBA2-WTIP fusion gene in acute myeloid leukemia.
Identifying and targeting oncogenic fusion genes have revolutionized the treatment of leukemia, such as PML-RARα fusion gene in acute promyelocytic leukemia. Here we identified an intrachromosomal fu...
Usefulness of polymerase chain reaction for diagnosing Whipple's disease in rheumatology.
To determine when Tropheryma whipplei polymerase chain reaction (PCR) is appropriate in patients evaluated for rheumatological symptoms.
Medical and Biotech [MESH] Definitions
Reverse Transcriptase Polymerase Chain Reaction
A variation of the PCR technique in which cDNA is made from RNA via reverse transcription. The resultant cDNA is then amplified using standard PCR protocols.
Genes, Pol
DNA sequences that form the coding region for retroviral enzymes including reverse transcriptase, protease, and endonuclease/integrase. "pol" is short for polymerase, the enzyme class of reverse transcriptase.
Reverse Transcriptase Inhibitors
Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template.
Multiplex Polymerase Chain Reaction
Methods for using more than one primer set in a polymerase chain reaction to amplify more than one segment of the target DNA sequence in a single reaction.
Real-time Polymerase Chain Reaction
Methods used for detecting the amplified DNA products from the polymerase chain reaction as they accumulate instead of at the end of the reaction.
