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

• ClinicalTrials.gov Identifier: NCT04200768
• Recruitment Status: Recruiting
• First Posted: December 16, 2019
• Last Update Posted: January 27, 2023
• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborator: KU Leuven
• Information provided by (Responsible Party): Universitaire Ziekenhuizen KU Leuven

Tracking Information

• First Submitted Date: November 21, 2019
• First Posted Date: December 16, 2019
• Last Update Posted Date: January 27, 2023
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2019)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Breast Neoplasms

Intervention

Other: Prospective data and sample collection

Performance of measurements of adiposity, extra collection of blood samples

Study Arms

Standard

Standard of care

Intervention: Other: Prospective data and sample collection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 13, 2019): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2024
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Marion Maetens, PhD; +3216321194; marion.maetens@kuleuven.be

• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT04200768
• Other Study ID Numbers: S63330
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Universitaire Ziekenhuizen KU Leuven
• Original Responsible Party: Giuseppe Floris, Universitaire Ziekenhuizen KU Leuven, Breast Pathologist, Department of Pathology
• Current Study Sponsor: Universitaire Ziekenhuizen KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: KU Leuven
• Investigators: Not Provided
• PRS Account: Universitaire Ziekenhuizen KU Leuven
• Verification Date: November 2022