Breast Cancer FemaleLICPNCT06907810
Study of Lipid Mediators in Chronic Postoperative Pain - LICP
A study testing Blood sample + questionnaire in people with Breast Cancer Female and Postoperative Pain, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Postoperative Pain
- What is being tested?
- Blood sample + questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Mar 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 older than 18 years
- Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
- Able to give informed consent
Who cannot join
- Men
- Women aged less than 18 years
- Pregnant women
- History of major psychiatric disorders
- Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa Martin, MSC contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc (UCLouvain)
Brussels, Brussels Capital, 1200
Martine Berlière, MD, PhD, 00327641075, martine.berliere@saintluc.uclouvain.be
Lisa Martin, MSC, 0032471089309, lisa.martin@uclouvain.be
About this study
Official title: Study of Lipid Mediators in Chronic Postoperative Pain Following Breast Cancer Surgery
This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.
The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (> 3 months) of postoperative pain after breast cancer surgery.
Read more
To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.
To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.
To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.
- Conditions
- Breast Cancer Female, Postoperative Pain
- Being tested
- Blood sample + questionnaire
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample + questionnaireOther
- blood sample before tumor surgery and at every follow-up visit
- questionnaire before tumor surgery and at every follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain | Experimental | Not described Receives: Other: Blood sample + questionnaire |
| No chronic pain | Active comparator | Not described Receives: Other: Blood sample + questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Measured: Throughout the study, an average of 2 years
Pain duration
Pain duration will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Measured: Throughout the study, an average of 2 years
Lipid Mediator Levels in Blood
Lipid mediator levels will be quantified in blood samples by LC-MS methods
Measured: Throughout the study, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start12 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Alhouayek, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907810
- Sponsor's protocol ID
- LICP
- Acronym
- LICP
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lipid Mediators in Chronic Postoperative Pain Following Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06907810
- Acronym / sponsor ID
- LICP / LICP
- Conditions
- Breast Cancer Female, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- 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.
This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.
The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (> 3 months) of postoperative pain after breast cancer surgery.
To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.
To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.
To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain | Experimental | Other: Blood sample + questionnaire |
| No chronic pain | Active comparator | Other: Blood sample + questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women older than 18 years
- Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
- Able to give informed consent
Key exclusion criteria (6 listed)
- Men
- Women aged less than 18 years
- Pregnant women
- History of major psychiatric disorders
- Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
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 |
|---|---|---|
| Blood sample + questionnaire* blood sample before tumor surgery and at every follow-up visit * questionnaire before tumor surgery and at every follow-up visit | Other | Chronic pain, No chronic pain |
Primary outcome
Pain intensity
Time frame: Throughout the study, an average of 2 years
Pain intensity will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Pain duration
Time frame: Throughout the study, an average of 2 years
Pain duration will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Lipid Mediator Levels in Blood
Time frame: Throughout the study, an average of 2 years
Lipid mediator levels will be quantified in blood samples by LC-MS methods
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- 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.
Lisa Martin, MSC contact
Mireille Alhouayek, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample + questionnaire in people with Breast Cancer Female and Postoperative Pain, run by Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine Berlière, MD, PhD (00327641075, martine.berliere@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Throughout the study, an average of 2 years). The study lists 3 primary outcomes in all. 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 2 Apr 2025.