Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

NCT02368275 | Completed

• 1 other identifier: Predictive cohort
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• neuropathic pain

  neuropathic pain assessed with the DN4 questionnaire

  3, 6 and 12 months after surgery in the prospective cohort

Secondary Outcomes (1)

• chronic postsurgical pain

  3, 6 and 12 months after surgery

Study Arms (2)

prospective cohort of patients undergoing mastectomy

Prospective cohort

cross sectional cohort of patients

Cross sectional cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead
• Hopital Foch: collaborator

Study Sites (2)

Hôpital Foch

Suresnes, Hauts De Seine, 92, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Related Publications (1)

• Sperandio G, Baudic S, Bennedsgaard K, Grosen K, Andersen IS, Finnerup NB, Albi-Feldzer A, Flor H, Nees F, Bouhassira D, Attal N. Somatic and psychological predictors of chronic postsurgical pain in cancer patients: a machine learning approach in a longitudinal two-centre study. Br J Anaesth. 2026 Jan 7:S0007-0912(25)00847-5. doi: 10.1016/j.bja.2025.12.002. Online ahead of print.

  PMID: 41506969 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The samples will use GWAS to detect potential genetic risk factors for neuropathic pain. These data will be analysed in Oxford laboratory (McCarthy).

Study Officials

• Nadine ATTAL, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 23, 2015
• Study Start: March 1, 2017
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

FR (2)