Informations générales (source: ClinicalTrials.gov)
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy: the Model of Chronic Myeloid Leukemia Treated with Tyrosine Kinase Inhibitors.
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
novembre 2023
novembre 2028
13 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | Philippe ROUSSELOT, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Emile Roux - Le Puy-en-Velay - France | Vanessa PANTE, Dr | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHRU Lille - Lille - France | Valérie COITEUX, MD | Contact (sur clinicalTrials) | |||
| CHU Annecy-Genevois - Annecy - France | Anne PARRY, MD | Contact (sur clinicalTrials) | |||
| CHU Caen - Caen - France | Atchroue JOHNSON ANSAH, MD | Contact (sur clinicalTrials) | |||
| CHU Créteil - Créteil - France | Lydia ROY, MD | Contact (sur clinicalTrials) | |||
| CHU de Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Marc BERGER, Pr | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - Grenoble - France | Mathieu MEUNIER, MD | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Amélie PENOT, MD | Contact (sur clinicalTrials) | |||
| CHU Nancy - Nancy - France | Gabrielle ROTH-GUEPI, MD | Contact (sur clinicalTrials) | |||
| CHU Rennes - Rennes - France | Martine ESCOFFRE-BARBE, MD | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - Saint-Étienne - France | Philippe RENAUDIER, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Paris Saclay - Site de Bicêtre - Paris - France | Laurence LEGROS, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Gabriel ETIENNE, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - Marseille - France | Aude CHARBONNIER, MD | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer de Toulouse - Oncopole - Toulouse - France | Françoise HUGUET, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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