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

November 10, 2017 updated by: Hopital Foch
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne, France, 92100
        • Hôpital Ambroise Paré
      • Saint Cloud, France, 92210
        • Centre René Huguenin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Transversal study
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
OTHER: Longitudinal study
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 months max

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Didier BOUHASSIRA, MD, AP-HP Hopital A. Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (ESTIMATE)

October 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/07
  • 2016-A00225-46 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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