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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06130787
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Clermont-Ferrand
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marc BERGER
Principal Investigator Affiliation	University Hospital, Clermont-Ferrand
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Leukemia,Myeloid, Chronic

Arms & Interventions

Arms

Experimental: All patients

Interventions

Biological: - 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

Contact a Trial Team

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International Sites

CHU Annecy-Genevois, Annecy, France

Status

Recruiting

Address

CHU Annecy-Genevois

Annecy, ,

Site Contact

Anne PARRY, MD

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