Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
NCT ID: NCT06130787
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
321 participants
INTERVENTIONAL
2023-11-17
2028-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All patients
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Marc BERGER
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Annecy-Genevois
Annecy, , France
Institut Bergonié
Bordeaux, , France
CHU Caen
Caen, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU Créteil
Créteil, , France
CHU Grenoble Alpes
Grenoble, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
CHRU Lille
Lille, , France
CHU Limoges
Limoges, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
CHU Nancy
Nancy, , France
Groupe Hospitalier Paris Saclay - Site de Bicêtre
Paris, , France
CHU Rennes
Rennes, , France
CHU Saint-Etienne
Saint-Etienne, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
CHU Versailles
Versailles, , France
Countries
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Central Contacts
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Facility Contacts
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Anne PARRY, MD
Role: primary
Gabriel ETIENNE, MD
Role: primary
Atchroue JOHNSON ANSAH, MD
Role: primary
Eric HERMET, MD
Role: backup
Clément LAHAYE, MD
Role: backup
Lydia ROY, MD
Role: primary
Mathieu MEUNIER, MD
Role: primary
Vanessa PANTE, Dr
Role: primary
Vanessa PANTE, MD
Role: backup
Valérie COITEUX, MD
Role: primary
Amélie PENOT, MD
Role: primary
Jean Baptiste FARGEAS, MD
Role: backup
Aude CHARBONNIER, MD
Role: primary
Gabrielle ROTH-GUEPI, MD
Role: primary
Jean-Yves NIEMIER, MD
Role: backup
Laurence LEGROS, MD
Role: primary
Emanuelle DURON, MD
Role: backup
Martine ESCOFFRE-BARBE, MD
Role: primary
Philippe RENAUDIER, MD
Role: primary
Blandine DELAVIGERIE, MD
Role: backup
Françoise HUGUET, MD
Role: primary
Clément GAUDIN, MD
Role: backup
Philippe ROUSSELOT, Pr
Role: primary
References
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Casile 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.
Other Identifiers
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2023-A00974-41
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2023 BERGER
Identifier Type: -
Identifier Source: org_study_id
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