Evaluation of ProALL miRs in Blood Specimen for Prediction of ALL Relapse Risk
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03000335|
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : February 4, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|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 2020|
|Estimated Study Completion Date :||December 2021|
B-ALL patients who have succumbed to relapse
B-ALL patients who are in remission
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
|Contact: Jennifer Yarden, PhDemail@example.com|
|Contact: Nir Dotan, PhDfirstname.lastname@example.org|
|Rambam Health Care Campus||Recruiting|
|Haifa, Israel, 3109601|
|Contact: Maysaa Saab-Kamal, BSc 972-4-777-4716 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Gil Gilad, MD|
|Study Chair:||Isaac Yaniv, MD||Schneider Children's Medical Center, Israel|