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

NCT02944721 | Withdrawn

• 2 other identifiers: 2016/072016-A00225-46
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Transversal study

OTHER

Patients who had surgery for breast cancer for 2 years or less

Genetic: Genetical analyses; Other: Chronic pain identification questionnaires; Other: Neurophysiological and psychophysical evaluations; Other: Quality of life questionnaires

Longitudinal study

OTHER

Patients that must be operated for a breast cancer

Genetic: Genetical analyses; Other: Chronic pain identification questionnaires; Other: Neurophysiological and psychophysical evaluations; Other: Quality of life questionnaires

Interventions

Genetical analyses GENETIC

Longitudinal study; Transversal study

Chronic pain identification questionnaires OTHER

Longitudinal study; Transversal study

Neurophysiological and psychophysical evaluations OTHER

Longitudinal study; Transversal study

Quality of life questionnaires OTHER

Longitudinal study; Transversal study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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
• Previous surgery for a breast cancer

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

Hopital Ambroise Paré

Boulogne, 92100, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Didier BOUHASSIRA, MD

  AP-HP Hopital A. Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 26, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: April 1, 2021
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)