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

NCT06939049 | Recruiting

• 1 other identifier: DDG_1039/2017_ASL_LE
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Development and realisation of non-invasive systems for the detection and quantification of biomarkers of Mesenchymal Epithelial Transition in blood and salivary samples.

  6 months

• 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

  6 months

Study Arms (4)

Lung cancer cohort

Breast cancer cohort

Control cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of subjects diagnosed with breast cancer or diagnosed with lung cancer, including mesothelioma.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ASL Lecce: lead

Study Sites (1)

Asl Lecce

Lecce, LECCE, 73100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary and bloody sample

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Prisco Piscitelli, Medical Doctor

CONTACT

0039 0832 661111; dreamfazzi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, sub-investigator

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: May 2, 2017
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)