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Completed

NCT Number: NCT02368275

Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Foch, Suresnes, Hauts De Seine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. neuropathic pain

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

    neuropathic pain assessed with the DN4 questionnaire

Secondary outcomes

  1. chronic postsurgical pain

    Time frame: 3, 6 and 12 months after surgery

    chronic pain questionnaire identification

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Collaborators

  • Hopital Foch

Registry information

Official study title

Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2015
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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