Actively Recruiting
Led by University Hospital, Clermont-Ferrand · Updated on 2024-09-27
321
Participants Needed
17
Research Sites
156 weeks
Total Duration
Researchers are studying adults newly diagnosed with chronic myeloid leukemia (CML) in the chronic phase to evaluate how biological age and individual frailty affect personalized cancer treatment with targeted therapy. This prospective, multicenter, open-label study aims to assess these factors using geriatric tools and DNA methylation analysis to better understand patients' health and aging in relation to their treatment. Participants will have their biological age measured through blood and optional bone marrow samples taken at the start, 3 months, and 12 months after diagnosis. Individual frailty and quality of life will be assessed using geriatric tools at the start and during follow-up visits at 6, 12, 24, and 36 months. All patients will receive first-line treatment with tyrosine kinase inhibitors, and the study will monitor their tolerance to this treatment over three years. During the study, participants will undergo evaluations including biological age determination, frailty assessments, and quality of life questionnaires at specified intervals. Researchers will also measure therapeutic response by quantifying disease markers over time and assess how well patients tolerate the medication. The total follow-up period lasts three years, with multiple assessments to track health status, treatment effects, and patient well-being.
CONDITIONS
Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 36 months
Participants undergo blood sampling and assessments of biological age, individual fragility, and quality of life while receiving tyrosine kinase inhibitor treatment.
Visits at Day 0, Month 3, Month 6, Month 12, Month 24, and Month 36 with additional assessment visits approximately every 3 months between Month 3 and Month 36
Total: 17 locations
1
CHU Annecy-Genevois
Annecy, France
Actively Recruiting
2
Institut Bergonié
Bordeaux, France
Not Yet Recruiting
3
CHU Caen
Caen, France
Actively Recruiting
4
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
5
CHU Créteil
Créteil, France
Not Yet Recruiting
6
CHU Grenoble Alpes
Grenoble, France
Not Yet Recruiting
7
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Actively Recruiting
8
CHRU Lille
Lille, France
Not Yet Recruiting
9
CHU Limoges
Limoges, France
Actively Recruiting
10
Centre Léon Bérard
Lyon, France
Withdrawn
11
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
12
CHU Nancy
Nancy, France
Actively Recruiting
13
Groupe Hospitalier Paris Saclay - Site de Bicêtre
Paris, France
Actively Recruiting
14
CHU Rennes
Rennes, France
Actively Recruiting
15
CHU Saint-Etienne
Saint-Etienne, France
Actively Recruiting
16
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Actively Recruiting
17
CHU Versailles
Versailles, France
Actively Recruiting
L
Lise LACLAUTRE
M
Mélanie CASILE, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Mélanie Casile, Gilles Albrand, Clément Lahaye...
https://pubmed.ncbi.nlm.nih.gov/38816821