Breast CancerDOLORISKSEINNCT02944721
Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
A study testing Genetical analyses, Chronic pain identification questionnaires and Neurophysiological and psychophysical evaluations in people with Breast Cancer, run by Hopital Foch at 2 sites in France.
Trial summary
The aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Genetical analyses, Chronic pain identification questionnaires and Neurophysiological and psychophysical evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2016to Apr 2021
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years
- Having given a written consent form
- Affiliated to the social security scheme
- French language (read, written and spoken)
- Accepting the principle of the study and able to respect the conditions of the study.
- Patients who can be followed during the total duration of the study ( 12 months) for the longitudinal arm of the forward-looking study
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- Patients that must be operated for one of the two types of surgery: preservative surgery or mastectomy for breast cancer with ganglionic cleaning out
- Chemotherapy or radiotherapy before the surgery
- patients operated for a conservative surgery or a mastectomy for breast cancer with ganglionic cleaning out during 2 years before the inclusion
Who cannot join
- Other cancer or AIDS in evolution
- Bilateral Mastectomy
- Presence of chronic pain before the intervention for breast cancer,
- occupational accident, dispute or search for compensation
- Previous surgery on the same territory
- Peripheral neurological pathology or central (brain damage, multiple sclerosis) susceptible to interfere with the evaluation of the post-operative pain
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- Heavy psychiatric histories: psychosis, severe depression having motivated a hospitalization, a suicide attempt
- Current major depressive episode at the time of the evaluation (cf. criterion diagnosis of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5))
- Abuse of drug or psychoactive substance (cf. definition of the DSM-5) during the last six months; cognitive disorders (MMSE 24/30) or psychological incompatible with the respect and/or the understanding of the protocol
- Patients participating in another protocol of biomedical research.
- For longitudinal study:
- Previous surgery for a breast cancer
- Patients that must be operated for a surgery of the breast without ganglionic cleaning out
- For transversal study:
- patients operated for a surgery of the breast without ganglionic cleaning out
- Patients operated for more than 2 years
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Ambroise Paré
Boulogne, 92100
Centre René Huguenin
Saint-Cloud, 92210
About this study
The aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . This will be realized on a transverse cohort ("Seintinelle"cohort) and confirmed on a forward-looking longitudinal cohort.
- Conditions
- Breast Cancer
- Being tested
- Genetical analyses, Chronic pain identification questionnaires, Neurophysiological and psychophysical evaluations, Quality of life questionnaires
- Keywords
- Neuropathic Pain
- Medical subject headings
- Breast Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetical analysesGenetic
Chronic pain identification questionnairesOther
Neurophysiological and psychophysical evaluationsOther
Quality of life questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Transversal study | Other | Patients who had surgery for breast cancer for 2 years or less Receives: Genetic: Genetical analyses; Other: Chronic pain identification questionnaires; Other: Neurophysiological and psychophysical evaluations; Other: Quality of life questionnaires |
| Longitudinal study | Other | Patients that must be operated for a breast cancer Receives: Genetic: Genetical analyses; Other: Chronic pain identification questionnaires; Other: Neurophysiological and psychophysical evaluations; Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between patients profile and type of pain
The genetic profile will be determined from a biological sample of blood taken at the willing patients. This analysis will include: an analysis of candidate genes, an analysis piece-genomics genome-wide association (GWAS) and newer techniques of sequencing of whole exome sequencing allowing to study variants with low and high impact.
The psychological profile will be determined by tests estimating the affect, the suffering, the capacities of management of the pain, the emotional regulation and the neuropsychological tests .
The neurophysiological profile will be determined by an evaluation quantified by the sensibility, the tests of painful conditioning stimulation, and the analysis of the excitability of nerve fibers.
Measured: 13 months max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2020 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: change of sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier BOUHASSIRA, MD, Principal investigator, AP-HP Hopital A. Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944721
- Sponsor's protocol ID
- 2016/07
- Other IDs
- 2016-A00225-46
- Acronym
- DOLORISKSEIN
- Status last verified
- Nov 2017
- First submitted
- 11 Oct 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
- ClinicalTrials.gov ID
- NCT02944721
- Acronym / sponsor ID
- DOLORISKSEIN / 2016/07
- Conditions
- Breast Cancer
- Keywords
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change of sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 26 Oct 2016 (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 aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . This will be realized on a transverse cohort ("Seintinelle"cohort) and confirmed on a forward-looking longitudinal cohort.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversal study | Other | Genetic: Genetical analyses, Other: Chronic pain identification questionnaires, Other: Neurophysiological and psychophysical evaluations, Other: Quality of life questionnairesPatients who had surgery for breast cancer for 2 years or less |
| Longitudinal study | Other | Genetic: Genetical analyses, Other: Chronic pain identification questionnaires, Other: Neurophysiological and psychophysical evaluations, Other: Quality of life questionnairesPatients that must be operated for a breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women over 18 years
- Having given a written consent form
- Affiliated to the social security scheme
- French language (read, written and spoken)
- Accepting the principle of the study and able to respect the conditions of the study.
Key exclusion criteria (16 listed)
- Other cancer or AIDS in evolution
- Bilateral Mastectomy
- Presence of chronic pain before the intervention for breast cancer,
- occupational accident, dispute or search for compensation
- Previous surgery on the same territory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetical analyses | Genetic | Longitudinal study, Transversal study |
| Chronic pain identification questionnaires | Other | Longitudinal study, Transversal study |
| Neurophysiological and psychophysical evaluations | Other | Longitudinal study, Transversal study |
| Quality of life questionnaires | Other | Longitudinal study, Transversal study |
Primary outcome
Correlation coefficient between patients profile and type of pain
Time frame: 13 months max
The genetic profile will be determined from a biological sample of blood taken at the willing patients. This analysis will include: an analysis of candidate genes, an analysis piece-genomics genome-wide association (GWAS) and newer techniques of sequencing of whole exome sequencing allowing to study variants with low and high impact. The psychological profile will be determined by tests estimating the affect, the suffering, the capacities of management of the pain, the emotional regulation and the neuropsychological tests . The neurophysiological profile will be determined by an evaluation quantified by the sensibility, the tests of painful conditioning stimulation, and the analysis of the excitability of nerve fibers.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Didier BOUHASSIRA, MD principal investigator
AP-HP Hopital A. Paré
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetical analyses, Chronic pain identification questionnaires and Neurophysiological and psychophysical evaluations in people with Breast Cancer, run by Hopital Foch 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 9 inclusion and 16 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: withdrawn, as of the sponsor's last update on 14 Nov 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation coefficient between patients profile and type of pain (time frame: 13 months max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2017.