Trial Title:
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
NCT ID:
NCT06130787
Condition:
Leukemia,Myeloid, Chronic
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Frailty
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Blood and bone marrow sample
Description:
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
Arm group label:
All patients
Summary:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Annecy-Genevois
Address:
City:
Annecy
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne PARRY, MD
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gabriel ETIENNE, MD
Facility:
Name:
CHU Caen
Address:
City:
Caen
Country:
France
Status:
Recruiting
Contact:
Last name:
Atchroue JOHNSON ANSAH, MD
Facility:
Name:
CHU de Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Status:
Recruiting
Contact:
Last name:
Marc BERGER, Pr
Email:
mberger@chu-clermontferrand.fr
Contact backup:
Last name:
Melanie CASILE, PhD
Phone:
+33473750682
Email:
mcasile@chu-clermont.fr
Contact backup:
Last name:
Eric HERMET, MD
Contact backup:
Last name:
Clément LAHAYE, MD
Facility:
Name:
CHU Créteil
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lydia ROY, MD
Facility:
Name:
CHU Grenoble Alpes
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mathieu MEUNIER, MD
Facility:
Name:
Centre Hospitalier Emile Roux
Address:
City:
Le Puy-en-Velay
Country:
France
Status:
Recruiting
Contact:
Last name:
Vanessa PANTE, Dr
Contact backup:
Last name:
Vanessa PANTE, MD
Facility:
Name:
CHRU Lille
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Valérie COITEUX, MD
Facility:
Name:
CHU Limoges
Address:
City:
Limoges
Country:
France
Status:
Recruiting
Contact:
Last name:
Amélie PENOT, MD
Contact backup:
Last name:
Jean Baptiste FARGEAS, MD
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Status:
Withdrawn
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Aude CHARBONNIER, MD
Facility:
Name:
CHU Nancy
Address:
City:
Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
Gabrielle ROTH-GUEPI, MD
Contact backup:
Last name:
Jean-Yves NIEMIER, MD
Facility:
Name:
Groupe Hospitalier Paris Saclay - Site de Bicêtre
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurence LEGROS, MD
Contact backup:
Last name:
Emanuelle DURON, MD
Facility:
Name:
CHU Rennes
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Martine ESCOFFRE-BARBE, MD
Facility:
Name:
CHU Saint-Etienne
Address:
City:
Saint-Étienne
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe RENAUDIER, MD
Contact backup:
Last name:
Blandine DELAVIGERIE, MD
Facility:
Name:
Institut Universitaire du Cancer de Toulouse - Oncopole
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Françoise HUGUET, MD
Contact backup:
Last name:
Clément GAUDIN, MD
Facility:
Name:
CHU Versailles
Address:
City:
Versailles
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe ROUSSELOT, Pr
Start date:
November 17, 2023
Completion date:
November 17, 2028
Lead sponsor:
Agency:
University Hospital, Clermont-Ferrand
Agency class:
Other
Source:
University Hospital, Clermont-Ferrand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06130787
