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

NCT04200768 | Recruiting

• 1 other identifier: S63330
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Body Mass Index; Adiposity; Obesity; Inflammatory Breast Cancer; Lobular Breast Cancer; Tumour Microenvironment

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Standard

OTHER

Standard of care

Other: Prospective data and sample collection

Interventions

Prospective data and sample collection OTHER

Performance of measurements of adiposity, extra collection of blood samples

Standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Inflammatory Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Marion Maetens, PhD

CONTACT

+3216321194; marion.maetens@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 16, 2019
• Study Start: September 1, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)