FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients. (FATLAS)
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|ClinicalTrials.gov Identifier: NCT04200768|
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : November 4, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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.|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||October 31, 2024|
|Estimated Study Completion Date :||October 31, 2024|
Standard of care
Other: Prospective data and sample collection
Performance of measurements of adiposity, extra collection of blood samples
- 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.
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
|Contact: Marion Maetens, PhDemail@example.com|
|Leuven, Belgium, 3000|
|Contact: Marion Maetens, PhD +3216321194 firstname.lastname@example.org|
|Contact: Tatjana Geukens, MD +3216321194 email@example.com|
|Sub-Investigator: Christine Desmedt, PhD|
|Principal Investigator: Giuseppe Floris, MD PhD|