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CompletedNCT02368275Updated Apr 30, 2021

Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

An observational study in Surgery, sponsored by Hospital Ambroise Paré Paris. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by Hospital Ambroise Paré Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Surgery

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03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 250 is above the median of 100 across 260 observational studies indexed under Neuralgia.

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Lead sponsor

Hospital Ambroise Paré Paris is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • prospective cohort of patients undergoing mastectomy

    Prospective cohort

  • cross sectional cohort of patients

    Cross sectional cohort

06

What researchers measure

Primary outcomes

  1. neuropathic pain

    neuropathic pain assessed with the DN4 questionnaire

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

Secondary outcomes

  1. chronic postsurgical pain

    chronic pain questionnaire identification

    Time frame: 3, 6 and 12 months after surgery

07

Study locations

2 sites
  • Hôpital Foch
    Suresnes, Hauts De Seine 92, France
  • Hôpital Ambroise Paré
    Boulogne Billancourt, 92100, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02368275
Lead sponsor
Hospital Ambroise Paré Paris
Collaborators
Hopital Foch
Responsible party
Nadine ATTAL (Principal investigator, Hospital Ambroise Paré Paris) — Principal investigator
First posted
Feb 23, 2015
Start date
Mar 1, 2017
Primary completion
Jul 30, 2020
Completion
Sep 30, 2020
Last update
Apr 30, 2021

Study contacts

Nadine ATTAL, MD, PhD
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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