Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
Recruiting now · Not applicable
Conditions studied: Leukemia,Myeloid, Chronic
In brief
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.
Key facts
- Study ID
- NCT06130787
- Run by
- University Hospital, Clermont-Ferrand
- People needed
- 321
- Starts
- 2023-11-17
- Expected to finish
- 2028-11-17
- Last updated by the study team
- 2024-09-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHU Versailles — Versailles, France (enrolling)
- Groupe Hospitalier Paris Saclay - Site de Bicêtre — Paris, France (enrolling)
- CHU Rennes — Rennes, France (enrolling)
- CHU Saint-Etienne — Saint-Etienne, France (enrolling)
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (enrolling)
- CHU Annecy-Genevois — Annecy, France (enrolling)
- CHU Caen — Caen, France (enrolling)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (enrolling)
- CHU Limoges — Limoges, France (enrolling)
- Institut Paoli-Calmettes — Marseille, France (enrolling)
- CHU Nancy — Nancy, France (enrolling)
- Institut Bergonié — Bordeaux, France
- Centre Léon Bérard — Lyon, France
- CHRU Lille — Lille, France
- CHU Créteil — Créteil, France
- CHU Grenoble Alpes — Grenoble, France
Full record on ClinicalTrials.gov
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