Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01650467
Eligibility Criteria:
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
Exclusion Criteria for CML patients already having undergone a follow-up visit at 12 months
* Known or suspected cause for resistance (dose reduced due to intolerance, digestive disease responsible for malabsorption ...)
Exclusion Criteria for the control population
* History or suspicion of hemopathy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01650467
Study Brief:
Protocol Section:
NCT01650467