Clinical trial · Interventional
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
NCT02944721CI-TRIAL-00030363DOLORISKSEINwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): change of sponsor
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chronic pain identification questionnaires | Other | — | UNRESOLVED |
| Genetical analyses | Genetic | — | UNRESOLVED |
| Neurophysiological and psychophysical evaluations | Other | — | UNRESOLVED |
| Quality of life questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Transversal study
- description
- Patients who had surgery for breast cancer for 2 years or less
- interventionNames
- Genetic: Genetical analyses
- Other: Chronic pain identification questionnaires
- Other: Neurophysiological and psychophysical evaluations
- Other: Quality of life questionnaires
- type
- OTHER
- label
- Longitudinal study
- description
- Patients that must be operated for a breast cancer
- interventionNames
- Genetic: Genetical analyses
- Other: Chronic pain identification questionnaires
- Other: Neurophysiological and psychophysical evaluations
- Other: Quality of life questionnaires
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.