- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02368275
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Boulogne Billancourt, Frankrig, 92100
- Hôpital Ambroise Paré
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Hauts De Seine
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Suresnes, Hauts De Seine, Frankrig, 92
- Hopital Foch
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
neuropathic pain
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
chronic postsurgical pain
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nadine ATTAL, MD, PhD, Principal Investigator
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Predictive cohort
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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