Clinical trial · Observational
Evaluation of ProALL miRs in Blood Specimen for Prediction of ALL Relapse Risk
Evaluation of ProALL microRNAs in Blood Specimen for Prediction of Acute Lymphoblastic Leukemia Relapse Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Relapse
- description
- B-ALL patients who have succumbed to relapse
- label
- Remission
- description
- B-ALL patients who are in remission
Primary outcomes (2)
- measure
- Stage 1: Abilty of miR-451, miR-151-5p and miR-1290 to Differentiate B-ALL Patients in Relapse from Patients in Remission
- timeFrame
- Maximum One and half years after enrollment of first patient
- description
- 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.
- measure
- Stage 2: Ability of miR-451, miR-151-5p and miR-1290 to Monitor B-ALL Patients
- timeFrame
- Three and a half years from enrollment of first patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDEckert C, Hagedorn N, Sramkova L, Mann G, Panzer-Grumayer R, Peters C, Bourquin JP, Klingebiel T, Borkhardt A, Cario G, Alten J, Escherich G, Astrahantseff K, Seeger K, Henze G, von Stackelberg A. Monitoring minimal residual disease in children with high-risk relapses of acute lymphoblastic leukemia: prognostic relevance of early and late assessment. Leukemia. 2015 Aug;29(8):1648-55. doi: 10.1038/leu.2015.59. Epub 2015 Mar 9. PMID 25748682
- BACKGROUNDChoi S, Henderson MJ, Kwan E, Beesley AH, Sutton R, Bahar AY, Giles J, Venn NC, Pozza LD, Baker DL, Marshall GM, Kees UR, Haber M, Norris MD. Relapse in children with acute lymphoblastic leukemia involving selection of a preexisting drug-resistant subclone. Blood. 2007 Jul 15;110(2):632-9. doi: 10.1182/blood-2007-01-067785. Epub 2007 Mar 19. PMID 17371950
- BACKGROUNDCoustan-Smith E, Sancho J, Hancock ML, Razzouk BI, Ribeiro RC, Rivera GK, Rubnitz JE, Sandlund JT, Pui CH, Campana D. Use of peripheral blood instead of bone marrow to monitor residual disease in children with acute lymphoblastic leukemia. Blood. 2002 Oct 1;100(7):2399-402. doi: 10.1182/blood-2002-04-1130. PMID 12239148
- BACKGROUNDHunger SP, Mullighan CG. Redefining ALL classification: toward detecting high-risk ALL and implementing precision medicine. Blood. 2015 Jun 25;125(26):3977-87. doi: 10.1182/blood-2015-02-580043. Epub 2015 May 21. PMID 25999453
- BACKGROUNDLocatelli F, Schrappe M, Bernardo ME, Rutella S. How I treat relapsed childhood acute lymphoblastic leukemia. Blood. 2012 Oct 4;120(14):2807-16. doi: 10.1182/blood-2012-02-265884. Epub 2012 Aug 15. PMID 22896001
- BACKGROUNDNguyen K, Devidas M, Cheng SC, La M, Raetz EA, Carroll WL, Winick NJ, Hunger SP, Gaynon PS, Loh ML; Children's Oncology Group. Factors influencing survival after relapse from acute lymphoblastic leukemia: a Children's Oncology Group study. Leukemia. 2008 Dec;22(12):2142-50. doi: 10.1038/leu.2008.251. Epub 2008 Sep 25.