Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy (BIO-TIMER)

University Hospital, Clermont-Ferrand

Status

Enrolling

Conditions

Leukemia,Myeloid, Chronic

Treatments

Biological: Blood and bone marrow sample

Study type

Interventional

Funder types

Other

Identifiers

NCT06130787

2023-A00974-41 (Other Identifier)

RBHP 2023 BERGER

Details and patient eligibility

About

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.

Enrollment

321 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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