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Clinical Trials/NCT02944721
NCT02944721
Withdrawn
Not Applicable

Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer

Hopital Foch2 sites in 1 countryNovember 2016
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Hopital Foch
Locations
2
Primary Endpoint
Correlation coefficient between patients profile and type of pain
Status
Withdrawn
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
April 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Correlation coefficient between patients profile and type of pain

Time Frame: 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.

Study Sites (2)

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