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

Not Applicable
Withdrawn
Conditions
Breast Cancer
Interventions
Genetic: Genetical analyses
Other: Chronic pain identification questionnaires
Other: Neurophysiological and psychophysical evaluations
Other: Quality of life questionnaires
Registration Number
NCT02944721
Lead Sponsor
Hopital Foch
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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.
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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.

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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Longitudinal studyNeurophysiological and psychophysical evaluationsPatients that must be operated for a breast cancer
Longitudinal studyGenetical analysesPatients that must be operated for a breast cancer
Transversal studyQuality of life questionnairesPatients who had surgery for breast cancer for 2 years or less
Transversal studyChronic pain identification questionnairesPatients who had surgery for breast cancer for 2 years or less
Longitudinal studyChronic pain identification questionnairesPatients that must be operated for a breast cancer
Transversal studyNeurophysiological and psychophysical evaluationsPatients who had surgery for breast cancer for 2 years or less
Transversal studyGenetical analysesPatients who had surgery for breast cancer for 2 years or less
Longitudinal studyQuality of life questionnairesPatients that must be operated for a breast cancer
Primary Outcome Measures
NameTimeMethod
Correlation coefficient between patients profile and type of pain13 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Hopital Ambroise Paré

🇫🇷

Boulogne, France

Centre René Huguenin

🇫🇷

Saint Cloud, France

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