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
- Diseases
- Chronic myeloid leukaemia
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Annecy-Genevois Coordinator of this site? Confirm its status | Annecy | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Chu Creteil Coordinator of this site? Confirm its status | Créteil | France | Not yet recruiting |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| Centre Hospitalier Emile Roux Coordinator of this site? Confirm its status | Le Puy-en-Velay | France | Recruiting |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| CHU Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Withdrawn |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU Nancy Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Groupe Hospitalier Paris Saclay - Site de Bicêtre Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Recruiting |
| Institut Universitaire du Cancer de Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU Versailles Coordinator of this site? Confirm its status | Versailles | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.