Development of New Methodologies and Innovative Tools for the diagnoSi and Therapeutic Treatment of uMAni Epithelial Tumors

Last updated: April 15, 2025
Sponsor: ASL Lecce
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06939049
DDG_1039/2017_ASL_LE
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Pregnant female patients of either sex under the age of 18 years, undergoingprevious drug therapy with corticosteroids, chemotherapies, immunosuppressants andanticancer drugs, as well as patients with a previous history of other malignanciesor 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).

Study Design

Total Participants: 250
Study Start date:
May 02, 2017
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Asl Lecce

    Lecce, 73100
    Italy

    Active - Recruiting

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