Back to resultsGenetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer (DOLORISKSEIN)
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Genetical analyses
Chronic pain identification questionnaires
Neurophysiological and psychophysical evaluations
Quality of life questionnaires
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Neuropathic Pain
Eligibility 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
Sites / Locations
- Hopital Ambroise Paré
- Centre René Huguenin
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Transversal study
Longitudinal study
Arm Description
Patients who had surgery for breast cancer for 2 years or less
Patients that must be operated for a breast cancer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02944721
Brief Title
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
Acronym
DOLORISKSEIN
Official Title
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
change of sponsor
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Neuropathic Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transversal study
Arm Type
Other
Arm Description
Patients who had surgery for breast cancer for 2 years or less
Arm Title
Longitudinal study
Arm Type
Other
Arm Description
Patients that must be operated for a breast cancer
Intervention Type
Genetic
Intervention Name(s)
Genetical analyses
Intervention Type
Other
Intervention Name(s)
Chronic pain identification questionnaires
Intervention Type
Other
Intervention Name(s)
Neurophysiological and psychophysical evaluations
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaires
Primary Outcome Measure Information:
Title
Correlation coefficient between patients profile and type of pain
Description
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.
Time Frame
13 months max
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier BOUHASSIRA, MD
Organizational Affiliation
AP-HP Hopital A. Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Ambroise Paré
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
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