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WT1 for the Detection of Minimal Residual Disease

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. Identifier: NCT00179829
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 15, 2008
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:
The purpose of this study is to determine if WT1 is an adequate measurement of minimal residual disease in leukemic patients.

Condition or disease Intervention/treatment Phase
Leukemia Cancer Procedure: WT 1 Testing Phase 2 Phase 3

Detailed Description:

Patients with acute Leukemia may have a large number of leukemic cells at the time that leukemia is evident clinically. At the time that we determine that a patient is in complete remission (CR) the patient may still have leukemic cells present in smaller quantities. One of the most important factors in the successful treatment of patients with leukemia is the ability to determine if the eradication of leukemia has been achieved. The determination of Minimal Residual Disease may be important in the determination of the therapy that a given patient will receive as determined by the level of residual disease.

WT1 gene function and expression. The WT1 gene is a candidate gene for Wilms tumor, which is thought to arise as a result from inactivation of both alleles of the WT1 gene located at chromosome 11p13. The WT1 gene has been considered a tumor suppressor gene because intragenic deletions or mutations are found in tumors, germline mutations have been found in-patients with leukemia, and mediates growth suppression of Wilms tumor cells expressing a WT1 splicing variant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Detection of Minimal Residual Disease in Newly Diagnosed Patients With Leukemia and Those Who Undergo a Bone Marrow Transplant Using the Wilms Tumor Suppressor Gene (WT1) as a Marker By RT-PCR
Study Start Date : February 1999
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Primary Outcome Measures :
  1. To assess the presence of the WT1 gene at the time of relapse in-patients with acute or chronic leukemia.
  2. To determine longitudinally its value as a marker for minimal residual disease (MRD) and its correlation to leukemia free survival after bone marrow transplantation.
  3. To assess the presence of the WT1 gene in newly diagnosed patients with leukemia (ALL, ANLL) at the time of diagnoses and during the course of their treatment and correlate it with leukemia free survival (LFS) and relapse.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age less than 21 years of age.
  • Patients with the following diseases: Acute lymphoblastic Leukemia (ALL) at the time of diagnoses or relapse, Acute non-lymphoblastic leukemia (ANLL) at diagnosis or after relapse and Chronic Myelogenous leukemia in chronic or accelerated phase.
  • Patients will be eligible for any of the available treatment protocols or protocols for stem cell transplantation, regardless of the source of stem cells.
  • Patients or legal guardians will sign an Institutional Review Board (IRB) approved informed consent.
  • Patients will have venous access or peripheral vein for sampling.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00179829

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United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
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Principal Investigator: Morris Kletzel, MD Ann & Robert H Lurie Children's Hospital of Chicago
Layout table for additonal information Identifier: NCT00179829    
Other Study ID Numbers: BMT 0399
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
acute lymphocytic leukemia
chronic myelogenous leukemia
acute myelogenous leukemia
Additional relevant MeSH terms:
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Neoplasm, Residual
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes