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

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ClinicalTrials.gov Identifier: NCT02944721
Recruitment Status : Withdrawn (change of sponsor)
First Posted : October 26, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Genetic: Genetical analyses Other: Chronic pain identification questionnaires Other: Neurophysiological and psychophysical evaluations Other: Quality of life questionnaires Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
Study Start Date : November 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944721


Locations
France
Hopital Ambroise Paré
Boulogne, France, 92100
Centre René Huguenin
Saint Cloud, France, 92210
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Didier BOUHASSIRA, MD AP-HP Hopital A. Paré

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02944721     History of Changes
Other Study ID Numbers: 2016/07
2016-A00225-46 ( Other Identifier: ANSM )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hopital Foch:
Neuropathic Pain

Additional relevant MeSH terms:
Breast Neoplasms
Neuralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms