NCT06907810

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

March 11, 2025

Last Update Submit

March 31, 2025

Conditions

Breast Cancer FemalePostoperative Pain

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

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

    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.

    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

    Throughout the study, an average of 2 years

Study Arms (2)

Chronic pain

EXPERIMENTAL
Other: Blood sample + questionnaire

No chronic pain

ACTIVE COMPARATOR
Other: Blood sample + questionnaire

Interventions

Blood sample + questionnaireOTHER

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

Chronic painNo chronic pain

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc (UCLouvain)

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mireille Alhouayek, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Berlière, MD, PhD

CONTACT

00327641075martine.berliere@saintluc.uclouvain.be

Lisa Martin, MSC

CONTACT

lisa.martin@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 2, 2025

Study Start

March 12, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)