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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00974-41 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and bone marrow sample | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biological age determination | The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage. | Day 0;Month 3;Month 12 |
| Individual fragility assessment | Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities. | Day 0;Month 6;Month 12;Month 24;Month 36 |
| Individual fragility assessment | Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life) | Day 0;Month 6;Month 12;Month 24;Month 36 |
| Tolerance of tyrosine kinase inhibitors | Tolerance assessed by actual dose received | Day 0;Month 3;Month 6;Month 12;Month 24;Month 36 |
| Tolerance of tyrosine kinase inhibitors | Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance | Day 0;Month 3;Month 6;Month 12;Month 24;Month 36 |
| Tolerance of tyrosine kinase inhibitors | Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0 | Day 0;Month 3;Month 6;Month 12;Month 24;Month 36 |
| Tolerance of tyrosine kinase inhibitors | Tolerance assessed by changes and number of tyrosine kinase inhibitor lines |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis. | Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities at the time of diagnosis. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr | |
| Mélanie CASILE, PhD | Contact | +33473750682 | mcasile@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marc BERGER | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Annecy-Genevois | Recruiting | Annecy | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38816821 | Derived | Casile M, Albrand G, Lahaye C, Lebecque B, Besombes J, Bourgne C, Pereira B, Saugues S, Jamot C, Hermet E, Berger MG. Value of combining biological age with assessment of individual frailty to optimize management of cancer treated with targeted therapies: model of chronic myeloid leukemia treated with tyrosine kinase inhibitors (BIO-TIMER trial). BMC Cancer. 2024 May 30;24(1):661. doi: 10.1186/s12885-024-12415-2. |
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|
| Day 0;Month 3;Month 6;Month 12;Month 24;Month 36 |
| Tolerance of tyrosine kinase inhibitors | Tolerance assessed by a description of treatment sequences | Day 0;Month 3;Month 6;Month 12;Month 24;Month 36 |
| Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis. |
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life) at the time of diagnosis. |
| Day 0 |
| Evaluation of therapeutic response through quantification of the BCR::ABL transcript | Quantification of BCR::ABL transcript expressed as copy number relative to 100 copies of control gene transcripts | Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36 |
| Assessment of therapeutic response by quantification of residual disease | Decrease in residual disease and achievement of MMR (≤0.1%), MR4 (≤0.01%), MR4.5 (≤0.032%), MR5 (≤0.001%) thresholds) | Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36 |
| Assessment of patients' quality of life | Quality of life assessed using the European Organisation for Research and Treatment of Cancer LG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients, with a higher score indicating a better health-related quality of life | Day 0;Month 6;Month 12;Month 24;Month 36 |
| Institut Bergonié | Not yet recruiting | Bordeaux | France |
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| CHU Caen | Recruiting | Caen | France |
|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
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| CHU Créteil | Not yet recruiting | Créteil | France |
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| CHU Grenoble Alpes | Not yet recruiting | Grenoble | France |
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| Centre Hospitalier Emile Roux | Recruiting | Le Puy-en-Velay | France |
|
| CHRU Lille | Not yet recruiting | Lille | France |
|
| CHU Limoges | Recruiting | Limoges | France |
|
| Centre Léon Bérard | Withdrawn | Lyon | France |
| Institut Paoli-Calmettes | Recruiting | Marseille | France |
|
| CHU Nancy | Recruiting | Nancy | France |
|
| Groupe Hospitalier Paris Saclay - Site de Bicêtre | Recruiting | Paris | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| CHU Saint-Etienne | Recruiting | Saint-Etienne | France |
|
| Institut Universitaire du Cancer de Toulouse - Oncopole | Recruiting | Toulouse | France |
|
| CHU Versailles | Recruiting | Versailles | France |
|
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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