Genetic, Neurophysiological and Psychological Risk Factor... | NCT02368275

Studies
Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

NCT02368275

Sponsor

Hospital Ambroise Paré Paris

Status

Completed

Last Update Posted

Apr 30, 2021Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Surgery

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jul 30, 2020Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Feb 13, 2015

First Submission Date that Met QC Criteria

Feb 13, 2015

First Posted Date

Feb 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2021

Last Update Posted Date

Apr 30, 2021Actual

Name	Class
Hopital Foch	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prospective cohort of patients undergoing mastectomy		Prospective cohort
cross sectional cohort of patients		Cross sectional cohort

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neuropathic pain	neuropathic pain assessed with the DN4 questionnaire	3, 6 and 12 months after surgery in the prospective cohort

Secondary Outcomes

Measure	Description	Time Frame
chronic postsurgical pain	chronic pain questionnaire identification	3, 6 and 12 months after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Nadine ATTAL, MD, PhD	Principal Investigator	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Foch		Suresnes	Hauts De Seine	92	France
Hôpital Ambroise Paré

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41506969	Derived	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 Apr;136(4):1330-1340. doi: 10.1016/j.bja.2025.12.002. Epub 2026 Jan 7.