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NCT Number: NCT04200768

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

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.

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Key information

Conditions

Breast Neoplasms Body Weight Breast Diseases Inflammatory Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prospective data and sample collection

Other

Performance of measurements of adiposity, extra collection of blood samples

Primary outcomes

  1. BMI

    Time frame: Before surgery

    Calculated: body mass (kg) divided by height squared (m²)

  2. Lipid levels in plasma

    Time frame: Before surgery

    Lipidomic analysis

  3. Up- or downregulation of pathways on single cell level

    Time frame: At surgery

    Single nucleus RNA sequencing using 10X Genomics Platform after dissociation of tissue into single nuclei

  4. T cell repertoire

    Time frame: At surgery

    Number of T-cells per population using immunohistochemical phenotypic markers of cell type and of exhaustion.

  5. Physical activity level

    Time frame: 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.

  6. Sleep behaviour score

    Time frame: Before surgery

    Pittsburgh Sleep Quality Index (PSQI) score (range: [0 - 21]). Higher scores indicate worse sleep quality.

  7. Dietary Quality Index

    Time frame: 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.

  8. Dietary Food Intake

    Time frame: Before surgery

    Food intake in kcal per day calculated using the in-house Food Frequency Questionnaire.

  9. Fat percentage

    Time frame: Before surgery

    Calculated from multiple frequency bio-impedance measurements (in %, range [0 - 100]).

  10. Waist-to-hip ratio

    Time frame: Before surgery

    Waist circumference (cm) divided by hip circumference (cm)

  11. Handgrip strength

    Time frame: Before surgery

    In kilograms (kg), measured by handheld dynamometer.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Acronym: FATLAS

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Dec 16, 2019
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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