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RecruitingNCT06907810LICPUpdated Apr 2, 2025

Study of Lipid Mediators in Chronic Postoperative Pain - LICP

An interventional study of Blood sample + questionnaire in Breast Cancer Female and Postoperative Pain, sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Breast Cancer Female
  • Postoperative Pain
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Chronic pain

    Other: Blood sample + questionnaire

  • Active comparator
    No chronic pain

    Other: Blood sample + questionnaire

Interventions

  • OtherBlood sample + questionnaire

    * blood sample before tumor surgery and at every follow-up visit * questionnaire before tumor surgery and at every follow-up visit

06

What researchers measure

Primary outcomes

  1. Pain intensity

    Pain intensity will be evaluated using a standardized questionnaire completed by participants at each medical consultation.

    Time frame: Throughout the study, an average of 2 years

  2. Pain duration

    Pain duration will be evaluated using a standardized questionnaire completed by participants at each medical consultation.

    Time frame: Throughout the study, an average of 2 years

  3. Lipid Mediator Levels in Blood

    Lipid mediator levels will be quantified in blood samples by LC-MS methods

    Time frame: Throughout the study, an average of 2 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

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 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06907810
Lead sponsor
Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
Mar 12, 2025
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Apr 2, 2025

Study contacts

Martine Berlière, MD, PhD
Contact
martine.berliere@saintluc.uclouvain.be
00327641075
Lisa Martin, MSC
Contact
lisa.martin@uclouvain.be
Mireille Alhouayek, PhD
principal investigator · Université Catholique de Louvain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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