Actively Recruiting
FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-06-28
150
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
FATLAS is a prospective, interventional, non Investigational Medicinal Product (IMP) study aiming to characterize the micro- and macroenvironment of breast cancer according to patient adiposity in different histological and molecular subtypes. The macroscopic profiling of the patient's adiposity will be based on Body Mass Index (BMI), bioimpedance analysis and waist-to-hip ratio. Blood samples will be taken for lipidomic analyses and for hormonal and immuno assays. Microscopic profiling of adiposity and inflammation will be done on fresh frozen (FF) and Formalin-Fixed Paraffin-Embedded (FFPE) samples from the tumour resection specimen and will consist of histological characterization, immuno assays, multiplex immunohistochemistry, DNA sequencing and single nuclei RNA sequencing both in the tumour and in adjacent normal mammary tissue.
CONDITIONS
Official Title
FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Histological confirmation of Invasive Ductal Carcinoma (IDC), Inflammatory Breast Cancer (IBC), or Invasive Lobular Carcinoma (ILC) on core diagnostic biopsy
- Willing and able to provide written informed consent
- Willing to provide plasma/blood and tissue samples
- Willing to have clinical measures of adiposity taken
- Stage I, II, or III non-metastatic breast cancer with any clinical lymph node status
- Scheduled for surgical tumor resection at UZ Leuven
- Tumor size of 1.5 cm or larger (exceptions for IBC patients after neoadjuvant treatment)
- Treatment-naive, meaning no systemic breast cancer treatment received prior to surgery (exceptions for IBC patients who had first line neoadjuvant chemotherapy before surgery)
You will not qualify if you...
- Pregnancy at time of diagnosis
- Personal history of breast cancer relapse or second primary
- Mixed invasive tumor type on core biopsy or special types other than pure ILC
- History of another progressing malignancy or one requiring active treatment in last 5 years (except treated basal or squamous cell skin cancers and in situ cervical cancer)
- Presence of immune dysregulatory disease requiring active immune modulatory treatment currently or in past 2 years (replacement therapies excluded)
- Any condition, therapy, or laboratory abnormality that may confound trial results as judged by the treating investigator
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
M
Marion Maetens, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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