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

Breast Cancer Clinical Trial

— DOLORISKSEIN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02944721
• Other study ID #: 2016/07
• Secondary ID: 2016-A00225-46
• Status: Withdrawn
• Phase: N/A
• First received: October 11, 2016
• Last updated: November 10, 2017
• Start date: November 2016
• Est. completion date: April 2021

Study information

• Verified date: November 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

For both arms:

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.

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuralgia

Intervention

Genetic:
• Genetical analyses

Other:
• Chronic pain identification questionnaires

• Neurophysiological and psychophysical evaluations

• Quality of life questionnaires

Locations

Country	Name	City	State
France	Hopital Ambroise Paré	Boulogne
France	Centre René Huguenin	Saint Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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