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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200768
Recruitment Status : Not yet recruiting
First Posted : December 16, 2019
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Giuseppe Floris, Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Other: Prospective data and sample collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200768


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

Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Contact: Marion Maetens, PhD    +3216321194    marion.maetens@kuleuven.be   
Contact: Tatjana Geukens, MD    +3216321194    tatjana.geukens@kuleuven.be   
Sub-Investigator: Christine Desmedt, PhD         
Principal Investigator: Giuseppe Floris, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
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Responsible Party: Giuseppe Floris, Breast Pathologist, Department of Pathology, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04200768    
Other Study ID Numbers: S63330
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Floris, Universitaire Ziekenhuizen Leuven:
Breast Cancer
Body Mass Index
Adiposity
Obesity
Inflammatory Breast Cancer
Lobular Breast Cancer
Tumour Microenvironment
Additional relevant MeSH terms:
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Breast Neoplasms
Obesity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight