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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00225-46 | Other Identifier | ANSM |
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change of sponsor
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The aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . This will be realized on a transverse cohort ("Seintinelle"cohort) and confirmed on a forward-looking longitudinal cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transversal study | Other | Patients who had surgery for breast cancer for 2 years or less |
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| Longitudinal study | Other | Patients that must be operated for a breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetical analyses | Genetic |
| ||
| Chronic pain identification questionnaires |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation coefficient between patients profile and type of pain | The genetic profile will be determined from a biological sample of blood taken at the willing patients. This analysis will include: an analysis of candidate genes, an analysis piece-genomics genome-wide association (GWAS) and newer techniques of sequencing of whole exome sequencing allowing to study variants with low and high impact. The psychological profile will be determined by tests estimating the affect, the suffering, the capacities of management of the pain, the emotional regulation and the neuropsychological tests . The neurophysiological profile will be determined by an evaluation quantified by the sensibility, the tests of painful conditioning stimulation, and the analysis of the excitability of nerve fibers. | 13 months max |
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For both arms:
Inclusion Criteria:
Exclusion Criteria:
For longitudinal study:
Inclusion Criteria:
Exclusion Criteria:
For transversal study:
Inclusion criteria:
- patients operated for a conservative surgery or a mastectomy for breast cancer with ganglionic cleaning out during 2 years before the inclusion
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Didier BOUHASSIRA, MD | AP-HP Hopital A. Paré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Ambroise Paré | Boulogne | 92100 | France | |||
| Centre René Huguenin |
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| Other |
|
| Neurophysiological and psychophysical evaluations | Other |
|
| Quality of life questionnaires | Other |
|
| Saint-Cloud |
| 92210 |
| France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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