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Evaluation of ProALL miRs in Blood Specimen for Prediction of ALL Relapse Risk

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ClinicalTrials.gov Identifier: NCT03000335
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Curewize Health Ltd.

Brief Summary:

Previous findings have shown that a biomarker comprised of the three microRNAs (miRs) miR-451, miR-151-5p and miR-1290 can independently predict precursor B-cell acute lymphoblastic leukemia (B- ALL) patients' risk for relapse when measured in cells from a bone marrow (BM) aspiration taken at diagnosis (Avigad et al., 2016: Genes, Chromosomes & Cancer 55:328-339). Curewize Health recognizes that the development of a minimally invasive blood test for frequent long-term monitoring can greatly benefit pediatric precursor B-ALL patients. Therefore, the current study will investigate the monitoring ability of miR-451, miR-151-5p and miR-1290 measured in blood samples. The study will be performed in two stages:

Stage 1-Cross-Sectional Study: Blood samples will be collected from relapsed pediatric B-ALL patients and B-ALL patients in remission. Blood will be collected from each patient in three tubes, for serum, plasma and whole blood analysis, in order to interpret the best blood source for measuring miR-451, miR-151-5p and miR-1290. The level of the miRs in blood will be compared between relapsed B-ALL patients to B-ALL patients in remission. If the Stage 1 Cross-Sectional study is successful, the investigators will continue the clinical trials to the Stage 2 Prospective Monitoring study.

Stage 2-Prospective Monitoring Study: Blood will be collected from patients at diagnosis and at routine clinical follow-up. Patients can be up to five years from diagnosis. The source of blood found to be most optimal for measuring the miR levels is Stage 1 will be collected. The final design of the Stage 2 study will be decided after completion of the Stage 1 study.


Condition or disease
B-cell Acute Lymphoblastic Leukemia

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Evaluation of ProALL microRNAs in Blood Specimen for Prediction of Acute Lymphoblastic Leukemia Relapse Risk
Study Start Date : December 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2021


Group/Cohort
Relapse
B-ALL patients who have succumbed to relapse
Remission
B-ALL patients who are in remission



Primary Outcome Measures :
  1. Stage 1: Abilty of miR-451, miR-151-5p and miR-1290 to Differentiate B-ALL Patients in Relapse from Patients in Remission [ Time Frame: Maximum One and half years after enrollment of first patient ]
    Investigate the ability of miR-451, miR-151-5p and miR-1290 measured in blood samples to differentiate between B-ALL patients who are in remission to patients who are in relapse.

  2. Stage 2: Ability of miR-451, miR-151-5p and miR-1290 to Monitor B-ALL Patients [ Time Frame: Three and a half years from enrollment of first patient ]
    Investigate the ability of miR-451, miR-151-5p and miR-1290 measured in blood samples as a surveillance monitoring tool to detect molecular relapse before overt clinical relapse and to confirm sustained molecular remission.


Secondary Outcome Measures :
  1. Stage 1: Optimal Blood Source for Measuring miR-451, miR-151-5p and miR-1290 for Monitoring B-ALL Patients [ Time Frame: Maximum One and half years after enrollment of first patient ]
    Investigate the optimal source of blood for the measurement of miR 451, miR-151-5p and miR-1290 for monitoring B-ALL patients for molecular relapse before overt clinical relapse and confirm sustained molecular remission.

  2. Stage 1: Decide if to Continue to Stage 2 Prospective Monitoring Study of the three miRs. [ Time Frame: Maximum One and half years after enrollment of first patient ]
    If results from Outcome 1 are positive then the study will continue to Stage 2.

  3. Stage 1: Finalize the design of Stage 2 Prospective Monitoring Study. [ Time Frame: Maximum One and half years after enrollment of first patient ]
    Sample size considerations and design of Stage 2 of the study will be finalized according to results of Stage 1.

  4. Stage 2: Combined Classifier for Monitoring B-ALL Patients for Overt Clinical Relapse or Sustained Remission [ Time Frame: Four years from enrollment of first patient ]
    Develop ProALL monitoring classifier based on the measurement of miR-451, miR 151-5p and miR-1290 in blood. An algorithm will be created that includes the most optimal combination and level changes of the microRNA to use as a surveillance monitoring tool of B-ALL patients.


Biospecimen Retention:   Samples Without DNA
Blood samples will be collected and transcribed to RNA. RNA samples will be retained.


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Ages Eligible for Study:   2 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • B-ALL patients at relapse
  • B-ALL patients at remission
Criteria

Inclusion Criteria:

  • Written inform consent was given for the clinical trial by the subject or subject's legally acceptable representative.
  • Patient with a final diagnosis of B-ALL
  • Male or Female
  • Age from 2 to 19 years at diagnosis.
  • Patient during remission at least 3 months after starting treatment.
  • Patient is up to five years from diagnosis at the baseline visit.
  • Patient at relapse before starting treatment for relapse.
  • Patient weighs at least 9.4 kg.

Exclusion Criteria:

  • Discovery of an alternative disorder other than B-cell acute lymphoblastic leukemia.
  • The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody or other dangerous contagious disease.

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 ClinicalTrials.gov identifier (NCT number): NCT03000335


Contacts
Contact: Jennifer Yarden, PhD 972-524897823 jenyarden@curewize.com
Contact: Nir Dotan, PhD 972-544516239 nirdotan@curewize.com

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Maysaa Saab-Kamal, BSc    972-4-777-4716    m_saab@rambam.health.gov.il   
Principal Investigator: Nira Arad-Cohen, MD         
Schneider Children's Medical Center of Israel Recruiting
Petah Tiqva, Israel, 4920235
Contact: Michal Rada, MPH    972-3-9253484    michalra6@clalit.org.il   
Principal Investigator: Gil Gilad, MD         
Sponsors and Collaborators
Curewize Health Ltd.
Investigators
Study Chair: Isaac Yaniv, MD Schneider Children's Medical Center, Israel

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: Curewize Health Ltd.
ClinicalTrials.gov Identifier: NCT03000335     History of Changes
Other Study ID Numbers: CW003
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Curewize Health Ltd.:
microRNA
relapse
blood
in vitro diagnostics
prediction
lab test

Additional relevant MeSH terms:
Epstein-Barr Virus Infections
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Recurrence
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma