Clinical trial · Interventional
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy: the Model of Chronic Myeloid Leukemia Treated with Tyrosine Kinase Inhibitors.
NCT06130787CI-TRIAL-00081137BIO-TIMERrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by DNA methylation analysis.
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 |
|---|---|---|---|
| Leukemia,Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and bone marrow sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- interventionNames
- Biological: Blood and bone marrow sample
Primary outcomes (8)
- measure
- Biological age determination
- timeFrame
- Day 0;Month 3;Month 12
- description
- The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage.
- measure
- Individual fragility assessment
- timeFrame
- Day 0;Month 6;Month 12;Month 24;Month 36
- description
- Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * CML in chronic phase at time of diagnosis. Diagnosis must be made no more than 3 months (90 days) prior to inclusion. Diagnosis of chronic-phase CML (European Leukemia Network \[ELN\] 2020 criteria; Baccarani et al 2013) with confirmation of a Philadelphia chromosome (Ph1). A cryptic Ph1 chromosome must be confirmed by FISH.Criteria must meet the definition of chronic phase CML * BCR ::ABL1 transcript quantifiable by quantitative PCR * 1st-line treatment with tyrosine kinase inhibitor * No tyrosine kinase inhibitor or hydroxyurea treatment received prior to first blood sampling (at diagnosis) * Signature of informed consent for CML Observatory and signature of informed consent for BIO-TIMER protocol * Read and understand French * Enrolled in a social security plan or beneficiary of such a plan Exclusion Criteria: * CML in accelerated or blast phase * Refusal to participate in the study * Treatment started prior to inclusion * Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice * Pregnant or breast-feeding women
References
Publications (1)
- DERIVEDCasile M, Albrand G, Lahaye C, Lebecque B, Besombes J, Bourgne C, Pereira B, Saugues S, Jamot C, Hermet E, Berger MG. Value of combining biological age with assessment of individual frailty to optimize management of cancer treated with targeted therapies: model of chronic myeloid leukemia treated with tyrosine kinase inhibitors (BIO-TIMER trial). BMC Cancer. 2024 May 30;24(1):661. doi: 10.1186/s12885-024-12415-2. PMID 38816821