FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.

Not Applicable

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Other: Prospective data and sample collection

• Registration Number: NCT04200768
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Study Start: 2020-09-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Inclusion of 30 lean (BMI 18.5 - 24.9 kg/m²), 30 overweight (BMI 25 - 29.9 kg/m²), and 30 obese (BMI ≥ 30 kg/m²) patients with histological confirmation of Invasive Ductal Carcinoma (IDC) on core diagnostic biopsy; 5 lean, 5 overweight and 5 obese Inflammatory Breast Cancer (IBC) patients; 15 lean, 15 overweight and 15 obese patients with histological confirmation of Invasive Lobular Carcinoma (ILC) on core diagnostic biopsy and 20 male subjects with any type of breast cancer that meet following criteria:

• be willing and able to provide written informed consent for this study;
• be willing to provide plasma/blood and tissue samples;
• be willing to have clinical measures of adiposity taken;
• have stage I, II or III disease (so non-metastatic) with any clinical lymph node status;
• be scheduled for surgical resection of the tumour in UZ Leuven.
• have a tumour size of ≥ 1.5 cm in order to have sufficient tumour material for the biomarker analysis. Exceptions will be made for IBC patients, as in some cases no residual tumour will be found after neoadjuvant treatment;
• be treatment naïve, i.e. not having received systemic breast cancer treatment prior to surgery. An exception is made for the IBC patients, as they will often have received first line neoadjuvant chemotherapy before surgery. IBC patients that do not undergo surgery after neoadjuvant treatment (e.g. because of inoperability of the patient) will not be included;

Exclusion Criteria

• pregnancy at time of diagnosis;
• personal history of breast cancer (relapse/second primary);
• mixed invasive tumour type on core biopsy or special type of breast carcinoma beside pure ILC;
• history of an additional malignancy that is progressing or that has required active treatment in the 5 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer;
• presence of an immune dysregulatory disease or condition which requires active immune modulatory treatment of any kind, or has required treatment in the past two years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
• history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial in the opinion of the treating investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard	Prospective data and sample collection	Standard of care

Primary Outcome Measures

Name	Time	Method
BMI	Before surgery	Calculated: body mass (kg) divided by height squared (m²)
Dietary Quality Index	Before surgery	Nutritional score (natural number, range \[0 - 100\]) calculated using the in-house Food Frequency Questionnaire. A score of \> 70 indicates healthy dietary behaviour.
Physical activity level	Before surgery	Time of activity of different intensities and time of sedentarity, evaluated using the Global Physical Activity Questionnaire (GPAQ) of the World Health Organisation (WHO) (scale: minutes per day, range \[0 - 1440\]). The higher the score for activity the better, the lower the score for sedentarity the better.
Handgrip strength	Before surgery	In kilograms (kg), measured by handheld dynamometer.
Lipid levels in plasma	Before surgery	Lipidomic analysis
Up- or downregulation of pathways on single cell level	At surgery	Single nucleus RNA sequencing using 10X Genomics Platform after dissociation of tissue into single nuclei
T cell repertoire	At surgery	Number of T-cells per population using immunohistochemical phenotypic markers of cell type and of exhaustion.
Sleep behaviour score	Before surgery	Pittsburgh Sleep Quality Index (PSQI) score (range: \[0 - 21\]). Higher scores indicate worse sleep quality.
Fat percentage	Before surgery	Calculated from multiple frequency bio-impedance measurements (in %, range \[0 - 100\]).
Dietary Food Intake	Before surgery	Food intake in kcal per day calculated using the in-house Food Frequency Questionnaire.
Waist-to-hip ratio	Before surgery	Waist circumference (cm) divided by hip circumference (cm)

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium