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Clinical Trials in France / NCT06130787
Recruiting Not applicable

Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy

NCT06130787 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Clermont-Ferrand
Phase
Not applicable
Started
2023-11-17
Last updated
2024-09-27

Condition(s) studied

Leukemia,Myeloid, Chronic

Investigational drug(s) / intervention(s)

Blood and bone marrow sample

Blood and bone marrow sample: Individual biological aging determined by DNA methylation analysis will be assessed at D0, M3 and M12. An optional bone marrow sample will be taken during the myelogram performed at diagnosis. Individual fragility and quality of life will be assessed using geriatric tools at D0, M6, M12, M24 and M36

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Biological age determination — Day 0;Month 3;Month 12
    The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage.
  • Individual fragility assessment — Day 0;Month 6;Month 12;Month 24;Month 36
    Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.
  • Individual fragility assessment — Day 0;Month 6;Month 12;Month 24;Month 36
    Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)
  • Tolerance of tyrosine kinase inhibitors — Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
    Tolerance assessed by actual dose received
  • Tolerance of tyrosine kinase inhibitors — Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
    Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance
  • Tolerance of tyrosine kinase inhibitors — Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
    Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0
  • Tolerance of tyrosine kinase inhibitors — Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
    Tolerance assessed by changes and number of tyrosine kinase inhibitor lines
  • Tolerance of tyrosine kinase inhibitors — Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
    Tolerance assessed by a description of treatment sequences

Trial sites (17)

FacilityCityRegionStatus
CHU Annecy-Genevois Annecy France Recruiting
Institut Bergonié Bordeaux France Not Yet Recruiting
CHU Caen Caen France Recruiting
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
CHU Créteil Créteil France Not Yet Recruiting
CHU Grenoble Alpes Grenoble France Not Yet Recruiting
Centre Hospitalier Emile Roux Le Puy-en-Velay France Recruiting
CHRU Lille Lille France Not Yet Recruiting
CHU Limoges Limoges France Recruiting
Centre Léon Bérard Lyon France Withdrawn
Institut Paoli-Calmettes Marseille France Recruiting
CHU Nancy Nancy France Recruiting
Groupe Hospitalier Paris Saclay - Site de Bicêtre Paris France Recruiting
CHU Rennes Rennes France Recruiting
CHU Saint-Etienne Saint-Etienne France Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse France Recruiting
CHU Versailles Versailles France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06130787 on ClinicalTrials.gov ↗ ← All trials in France