NCT06939049Completed
Development of New Methodologies and Innovative Tools for the diagnoSi and Therapeutic Treatment of uMAni Epithelial Tumors
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 15 Apr 2025
- Start date
- 2 May 2017
- Primary completion date
- 31 Jul 2021
- Lead sponsor
- ASL Lecce
- Diseases
- Lung cancer
- NCT number
- NCT06939049
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From 2 May 2017 to the primary completion date, 31 Jul 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asl Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.