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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: Prospective data and sample collection

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Maetens, PhD; Phone Number: +3216321194; Email: marion.maetens@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Marion Maetens, PhD; Phone Number: +3216321194; Email: marion.maetens@kuleuven.be
    • Contact: Tatjana Geukens, MD; Phone Number: +3216321194; Email: tatjana.geukens@kuleuven.be
    • Sub-Investigator: Christine Desmedt, PhD
    • Principal Investigator: Giuseppe Floris, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard; Standard of care	Other: Prospective data and sample collection; Performance of measurements of adiposity, extra collection of blood samples

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Breast Cancer; Body Mass Index; Adiposity; Inflammatory Breast Cancer; Lobular Breast Cancer; Tumour Microenvironment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Breast Neoplasms; Obesity
• Other Study ID Numbers: S63330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No