Clinical trial NCT02368275: Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain
Official title: Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
Collaborators: name: Hopital Foch
First posted: 2015-02-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The objective of these cohorts is to detect potential genetic, neurophysiological psychological and cognitive risk factors for the development of chronic postsurgical pain including neuropathic pain.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: neuropathic pain
timeFrame: 3, 6 and 12 months after surgery in the prospective cohort
Secondary outcomes:
measure: chronic postsurgical pain
timeFrame: 3, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
state: Hauts De Seine
city: Boulogne Billancourt
country: France
facility: Hôpital Ambroise Paré
Study officials:
affiliation: Principal Investigator
name: Nadine ATTAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: