Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain
Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This new study will enroll patients undergoing mastectomy or thoracotomy for cancer. They will be three cohorts :
- one prospective cohort constituted of women undergoing breast surgery in René Huguenin Hospital (Saint Cloud) and followed for up to one year after surgery.
- another cross sectional cohort constituted of patient association (Seintinelle) including women operated up to 2 years previously from breast surgery.
- One prospective cohort constituted of women or men undergoing thoracotomy in Foch hospital (Suresnes) and followed for up to one year after surgery.
The main objectives of these cohorts will be to detect potential genetic, neurophysiological, psychological and cognitive risk factors for the development of chronic postsurgical neuropathic pain.
These patients will questioned about demographics, age, sex, body mass index. A large neuropsychological and psychological battery of tests will be conducted. Sensory function will assessed using quantitative sensory testing. Biological samples will analyse potential genetic factors in the development of neuropathic pain after surgery. Conditioned pain modulation, threshold tracking and quantitative sensory testing will also be assessed in subgroup of patients.
The prospective cohort will be assessed before surgery then 3, 6 and 12 months after surgery. The cross sectional cohort will be assessed during one to two visits in hospital.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Boulogne Billancourt, Francia, 92100
- Hôpital Ambroise Paré
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Hauts De Seine
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Suresnes, Hauts De Seine, Francia, 92
- Hôpital Foch
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The first group of patients consists of women recruited from René Huguenin Hospital (Saint Cloud, Ile de France) for mastectomy or lumpectomy to treat breast cancer, with axillary lymph node dissection in all cases.
The second cohort will consist of women already operared of breast surgery in the last 2 years.
The third cohort will consist of men or women recruited from Foch hospital (Suresnes, Ile de France) for thoracotomy for cancer.
Descrizione
Inclusion Criteria:
- Patients undergoing surgery for breast cancer or thoracotomy for lung cancer followed during the course of the study or patients from the French cohort Seintinelle already operated from breast surgery over the past 2 years.
Exclusion criteria :
- Patients are not included if they have clinically significant or unstable psychiatric or somatic conditions (e.g. major depression, psychosis, uncontrolled diabetes mellitus or hypertension, neurological disorders, immune disease, body mass index > 45), past or present substance abuse or any cognitive deterioration based on past medical history, semi-structured interview and lack of completion or full understanding of questionnaires.
- Bilateral mastectomy (for women undergoing breast surgery)
- Presence of pain before surgery
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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prospective cohort of patients undergoing mastectomy
Prospective cohort
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cross sectional cohort of patients
Cross sectional cohort
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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neuropathic pain
Lasso di tempo: 3, 6 and 12 months after surgery in the prospective cohort
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neuropathic pain assessed with the DN4 questionnaire
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3, 6 and 12 months after surgery in the prospective cohort
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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chronic postsurgical pain
Lasso di tempo: 3, 6 and 12 months after surgery
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chronic pain questionnaire identification
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3, 6 and 12 months after surgery
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Nadine ATTAL, MD, PhD, Principal Investigator
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Predictive cohort
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