SurgeryNCT02368275
Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain
An observational study of Surgery, run by Hospital Ambroise Paré Paris at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2017to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Foch
Suresnes, Hauts De Seine, 92
About this study
Official title: Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer
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.
- Conditions
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort of patients undergoing mastectomy | Prospective cohort | |
| cross sectional cohort of patients | Cross sectional cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropathic pain
neuropathic pain assessed with the DN4 questionnaire
Measured: 3, 6 and 12 months after surgery in the prospective cohort
Secondary outcomes (1)
chronic postsurgical pain
chronic pain questionnaire identification
Measured: 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start1 Mar 2017
- Primary completion30 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Foch
- Responsible party
- Principal investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Nadine ATTAL, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368275
- Sponsor's protocol ID
- Predictive cohort
- Status last verified
- Apr 2021
- First submitted
- 13 Feb 2015
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41506969
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer
- ClinicalTrials.gov ID
- NCT02368275
- Acronym / sponsor ID
- Predictive cohort
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Collaborators
- Hopital Foch
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective cohort of patients undergoing mastectomy | – | –Prospective cohort |
| cross sectional cohort of patients | – | –Cross sectional cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neuropathic pain
Time frame: 3, 6 and 12 months after surgery in the prospective cohort
neuropathic pain assessed with the DN4 questionnaire
1 secondary outcome
chronic postsurgical pain
Time frame: 3, 6 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 41506969Sperandio 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine ATTAL, MD, PhD principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Hospital Ambroise Paré Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropathic pain (time frame: 3, 6 and 12 months after surgery in the prospective cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.