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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00639-34 | Other Identifier | RCB number |
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Funding is late, unforseeable.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | 60 healthy controls with no hematological pathologies | ||
| Imatinib optimal response | 30 CML patients who are optimal responders to imatinib treatment | ||
| Imatinib primary resistance | 30 CML patients who have primary resistance to imatinib treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| abl genotype | The abl genotype will be determined for all subjects | baseline ; at diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| abl genotype | The abl genotype will be determined for all subjects | 12 months after diagnosis |
| bcr-abl leucemic fraction genotype | The bcr-able leucemic fraction genotype will be determined for CML patients |
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Inclusion Criteria:
Inclusion Criteria for all CML patients
Inclusion Criteria for CML patients already having undergone a follow-up visit at 12 months
Inclusion Criteria for the optimal response group:
Inclusion criteria for the primary resistance group
Inclusion Criteria for the control population
Exclusion Criteria:
Exclusion Criteria for CML patients already having undergone a follow-up visit at 12 months
Exclusion Criteria for the control population
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We will include 60 healthy controls (free of hematologic pathology, seen in genetic counseling) and stratify the recruitment of patients with CML among 30 patients with optimal imatinib response and 30 with primary resistance.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste Gaillard, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du Parc | Castelnau-le-Lez | 34170 | France | |||
| CHU de Montpellier - Hôpital Saint-Eloi |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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Two 7 ml EDTA tubes for genotyping abl and bcr-abl polymorphisms
| 12 months after diagnosis |
| bcr-abl leucemic fraction genotype | The bcr-able leucemic fraction genotype will be determined for CML patients | baseline ; at diagnosis |
| abl non-leucemic fraction genotype | The abl non-leucemic fraction genotype will be determined for CML patients | baseline ; at diagnosis |
| abl non-leucemic fraction genotype | The abl non-leucemic fraction genotype will be determined for CML patients | 12 months after diagnosis |
| Montpellier |
| 34295 |
| France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| 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 |