Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Hopital Foch
- 试验地点
- 4
- 主要终点
- Correlation coefficient between patients profile and type of pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years
- •Having given a written consent form
- •Affiliated to the social security scheme
- •French language (read, written and spoken)
- •Accepting the principle of the study and able to respect the conditions of the study.
排除标准
- •Other cancer or AIDS in evolution
- •Bilateral Mastectomy
- •Presence of chronic pain before the intervention for breast cancer,
- •occupational accident, dispute or search for compensation
- •Previous surgery on the same territory
- •Peripheral neurological pathology or central (brain damage, multiple sclerosis) susceptible to interfere with the evaluation of the post-operative pain
- •Heavy psychiatric histories: psychosis, severe depression having motivated a hospitalization, a suicide attempt
- •Current major depressive episode at the time of the evaluation (cf. criterion diagnosis of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5))
- •Abuse of drug or psychoactive substance (cf. definition of the DSM-5) during the last six months; cognitive disorders (MMSE 24/30) or psychological incompatible with the respect and/or the understanding of the protocol
- •Patients participating in another protocol of biomedical research.
- •For longitudinal study:
- •Inclusion Criteria:
- •Patients who can be followed during the total duration of the study ( 12 months) for the longitudinal arm of the forward-looking study
- •Patients that must be operated for one of the two types of surgery: preservative surgery or mastectomy for breast cancer with ganglionic cleaning out
- •Chemotherapy or radiotherapy before the surgery
- •Exclusion Criteria:
- •Previous surgery for a breast cancer
- •Patients that must be operated for a surgery of the breast without ganglionic cleaning out
- •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
- •patients operated for a surgery of the breast without ganglionic cleaning out
- •Patients operated for more than 2 years
研究组 & 干预措施
Transversal study
Patients who had surgery for breast cancer for 2 years or less
干预措施: Neurophysiological and psychophysical evaluations (Other)
Transversal study
Patients who had surgery for breast cancer for 2 years or less
干预措施: Quality of life questionnaires (Other)
Transversal study
Patients who had surgery for breast cancer for 2 years or less
干预措施: Genetical analyses (Genetic)
Transversal study
Patients who had surgery for breast cancer for 2 years or less
干预措施: Chronic pain identification questionnaires (Other)
Longitudinal study
Patients that must be operated for a breast cancer
干预措施: Neurophysiological and psychophysical evaluations (Other)
Longitudinal study
Patients that must be operated for a breast cancer
干预措施: Quality of life questionnaires (Other)
Longitudinal study
Patients that must be operated for a breast cancer
干预措施: Genetical analyses (Genetic)
Longitudinal study
Patients that must be operated for a breast cancer
干预措施: Chronic pain identification questionnaires (Other)
结局指标
主要结局
Correlation coefficient between patients profile and type of pain
时间窗: 13 months max
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.
次要结局
未报告次要终点