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

NCT ID: NCT06939049

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2025-12-31

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.

Conditions

Cancer Risk; Breast Cancer Risk; Lung Cancer (NSCLC)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Lung cancer cohort

No interventions assigned to this group

Breast cancer cohort

No interventions assigned to this group

Control cohort

No interventions assigned to this group

Multiple cancer cohort (Gastrointestinal, urogenital, brain, haematologic cancer)

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ASL Lecce

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prisco Piscitelli

Medical Doctor, sub-investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asl Lecce

Lecce, LECCE, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Prisco Piscitelli, Medical Doctor

Role: CONTACT

dreamfazzi@gmail.com

0039 0832 661111

Facility Contacts

Prisco Piscitelli, Medical Doctor

Role: primary

0039 0832 661111

Other Identifiers

DDG_1039/2017_ASL_LE

Identifier Type: -

Identifier Source: org_study_id