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

Breast Neoplasms Clinical Trial

— FATLAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04200768
• Other study ID #: S63330
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Marion Maetens, PhD
• Phone: +3216321194
• Email: marion.maetens[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Obesity

Intervention

Other:
• Prospective data and sample collection
Performance of measurements of adiposity, extra collection of blood samples

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Calculated: body mass (kg) divided by height squared (m²)	Before surgery
Primary	Lipid levels in plasma	Lipidomic analysis	Before surgery
Primary	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
Primary	T cell repertoire	Number of T-cells per population using immunohistochemical phenotypic markers of cell type and of exhaustion.	At surgery
Primary	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
Primary	Sleep behaviour score	Pittsburgh Sleep Quality Index (PSQI) score (range: [0 - 21]). Higher scores indicate worse sleep quality.	Before surgery
Primary	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
Primary	Dietary Food Intake	Food intake in kcal per day calculated using the in-house Food Frequency Questionnaire.	Before surgery
Primary	Fat percentage	Calculated from multiple frequency bio-impedance measurements (in %, range [0 - 100]).	Before surgery
Primary	Waist-to-hip ratio	Waist circumference (cm) divided by hip circumference (cm)	Before surgery
Primary	Handgrip strength	In kilograms (kg), measured by handheld dynamometer.	Before surgery