Leukemia, Myeloid, Chronic-Phase
Conditions
Keywords
abl polymorphisms
Brief summary
The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.
Detailed description
The first secondary objective of this study is to identify, in patients not responding to treatment, possible changes in the polymorphisms of interest during the course of the disease, reclassifying such polymorphisms as mutations. The second secondary objective is to compare the control patients in terms of polymorphism frequency on the nonpathological abl fraction.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan Inclusion Criteria for all CML patients * Patients diagnosed with CML * Treatment with Imatinib in first-line monotherapy and this for at least 12 months * RNA and / or cDNA used for diagnosis correctly stored in the biobank Inclusion Criteria for CML patients already having undergone a follow-up visit at 12 months * RNA and / or cDNA used for diagnosis/follow-up correctly stored in the biobank * Cytogenetic results are available * Absence of ITK mutation for the primary resistance subgroup * Validated compliance Inclusion Criteria for the optimal response group: * bcr-abl typing is less than 0.1% at 12 months Inclusion criteria for the primary resistance group * bcr-abl typings is \>1% and/or Philadelphia+ is greater than 0 Inclusion Criteria for the control population * Absence of hematologic malignancy
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The patient has a contraindication for a treatment used in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| abl genotype | baseline ; at diagnosis | The abl genotype will be determined for all subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| abl genotype | 12 months after diagnosis | The abl genotype will be determined for all subjects |
| bcr-abl leucemic fraction genotype | 12 months after diagnosis | The bcr-able leucemic fraction genotype will be determined for CML patients |
| abl non-leucemic fraction genotype | baseline ; at diagnosis | The abl non-leucemic fraction genotype will be determined for CML patients |
Countries
France
Outcome results
None listed