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

Last updated: September 26, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Treatment

Blood and bone marrow sample

Clinical Study ID

NCT06130787
RBHP 2023 BERGER
2023-A00974-41
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • CML in chronic phase at time of diagnosis. Diagnosis must be made no more than 3months (90 days) prior to inclusion. Diagnosis of chronic-phase CML (EuropeanLeukemia Network [ELN] 2020 criteria; Baccarani et al 2013) with confirmation of aPhiladelphia chromosome (Ph1). A cryptic Ph1 chromosome must be confirmed byFISH.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 bloodsampling (at diagnosis)

  • Signature of informed consent for CML Observatory and signature of informed consentfor BIO-TIMER protocol

  • Read and understand French

  • Enrolled in a social security plan or beneficiary of such a plan

Exclusion

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 ofjustice

  • Pregnant or breast-feeding women

Study Design

Total Participants: 321
Treatment Group(s): 1
Primary Treatment: Blood and bone marrow sample
Phase:
Study Start date:
November 17, 2023
Estimated Completion Date:
November 17, 2028

Connect with a study center

  • CHU Annecy-Genevois

    Annecy,
    France

    Active - Recruiting

  • Institut Bergonié

    Bordeaux,
    France

    Site Not Available

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHU Créteil

    Créteil,
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble,
    France

    Site Not Available

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay,
    France

    Active - Recruiting

  • CHRU Lille

    Lille,
    France

    Site Not Available

  • CHU Limoges

    Limoges,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille,
    France

    Active - Recruiting

  • CHU Nancy

    Nancy,
    France

    Active - Recruiting

  • Groupe Hospitalier Paris Saclay - Site de Bicêtre

    Paris,
    France

    Active - Recruiting

  • CHU Rennes

    Rennes,
    France

    Active - Recruiting

  • CHU Saint-Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse,
    France

    Active - Recruiting

  • CHU Versailles

    Versailles,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.