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NCT06130787Recruiting

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

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.

Source: ClinicalTrials.gov · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
321 (estimated)
First submitted
29 Sept 2023
Start date
17 Nov 2023
Primary completion date
17 Nov 2025
Lead sponsor
University Hospital, Clermont-Ferrand
NCT number
NCT06130787

What you commit to

  • Study type: Interventional
  • Planned participants: 321
  • From 17 Nov 2023 to the primary completion date, 17 Nov 2025
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment started prior to inclusion

Other

  • CML in accelerated or blast phase
  • Refusal to participate in the study
  • Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice
  • Pregnant or breast-feeding women

Who the study is looking for

  • 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Annecy-Genevois
Coordinator of this site? Confirm its status
AnnecyFranceRecruiting
Institut Bergonie
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceRecruiting
CHU de Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceRecruiting
Chu Creteil
Coordinator of this site? Confirm its status
CréteilFranceNot yet recruiting
CHU Grenoble Alpes
Coordinator of this site? Confirm its status
GrenobleFranceNot yet recruiting
Centre Hospitalier Emile Roux
Coordinator of this site? Confirm its status
Le Puy-en-VelayFranceRecruiting
CHRU Lille
Coordinator of this site? Confirm its status
LilleFranceNot yet recruiting
CHU Limoges
Coordinator of this site? Confirm its status
LimogesFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceWithdrawn
Institut Paoli-Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
CHU Nancy
Coordinator of this site? Confirm its status
NancyFranceRecruiting
Groupe Hospitalier Paris Saclay - Site de Bicêtre
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU Rennes
Coordinator of this site? Confirm its status
RennesFranceRecruiting
CHU Saint-Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceRecruiting
Institut Universitaire du Cancer de Toulouse - Oncopole
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHU Versailles
Coordinator of this site? Confirm its status
VersaillesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.