Clinical trial NCT06939049: Development of New Methodologies and Innovative Tools for the diagnoSi and Therapeutic Treatment of uMAni Epithelial Tumors
Official title: Development of New Methodologies and Innovative Tools for the diagnoSi and Therapeutic Treatment of uMAni Epithelial Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Risk
Breast Cancer Risk
Lung Cancer (NSCLC)
Lead sponsor: ASL Lecce
Sponsor class: OTHER_GOV
First posted: 2025-04-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of subjects diagnosed with breast cancer or diagnosed with lung cancer, including mesothelioma.

Brief summary: The main objective of the SISTEMA project is to develop non-invasive diagnostic tests for the detection and quantification in blood of markers of Mesenchymal Epithelial Transition, a mechanism that characterises certain types of cancer such as breast and lung cancer. Cancer is still one of the leading causes of death in Western countries. In 2014, there were an estimated 1,665,540 new cancer cases and 585,720 deaths in the United States alone. The World Health Organisation (WHO) and Eurostat predict 1,323,600 deaths in Europe, a figure slightly down on previous statistics but still underlining the existence and seriousness of the problem. It is no coincidence that cancer is one of the main areas of investment in the European Horizon 2020 programme. In recent years, the hypothesis that the process of carcinogenesis is driven by the activation of a particular panel of genes/proteins that enable cancer cells to acquire malignant characteristics has become increasingly popular. This process goes by the name Epithelial Mesenchymal Transition (EMT) and characterises all human epithelial tumours. This process allows epithelial tumour cells to acquire mesenchymal characteristics giving them stem, invasive, and chemoresistant properties.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects over the age of 18 years with an established clinical picture of breast or lung cancer (including mesothelioma) who have not yet started chemotherapy or biological therapies for the treatment of the neoplastic disease and who have read, understood and signed the study information sheet with attached Informed Consent to Participation, signing the attached consent.

Exclusion Criteria:

* Pregnant female patients of either sex under the age of 18 years, undergoing previous drug therapy with corticosteroids, chemotherapies, immunosuppressants and anticancer drugs, as well as patients with a previous history of other malignancies or in a terminal state (life expectancy less than 4 weeks).

Furthermore, lung cancer patients with conditions that could potentially interfere metabolically with the L-fucose biomarker tested in the specific project arm will be excluded, i.e. lung cancer patients simultaneously suffering from: cirrhosis of the liver, gastric ulcer, diabetes mellitus, periodontitis, as well as subjects under stressful conditions (in which false positivity to the marker due to adrenalin release could occur).

Primary outcomes:
measure: Development and realisation of non-invasive systems for the detection and quantification of biomarkers of Mesenchymal Epithelial Transition in blood and salivary samples.
timeFrame: 6 months
measure: Validation of innovative biomarkers for the diagnosis and monitoring of therapeutic efficacy in epithelial-mesenchymal transition tumours, primarily breast and lung cancer.Development and implementation of non-invasive systems for the detection and quant
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lecce
country: Italy
facility: Asl Lecce
Study officials:
References: