New methods for diagnosing and treating certain types of cancer
Development of New Methodologies and Innovative Tools for the diagnoSi and Therapeutic Treatment of uMAni Epithelial Tumors
ASL Lecce · NCT06939049
This study is testing new blood tests to see if they can help find and measure cancer markers in people with breast and lung cancers before they start treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ASL Lecce (other gov) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lecce) |
| Trial ID | NCT06939049 on ClinicalTrials.gov |
What this trial studies
The SISTEMA project aims to develop non-invasive blood tests to detect and quantify markers associated with Mesenchymal Epithelial Transition, which is relevant for breast and lung cancers. By identifying these markers, the study seeks to improve early diagnosis and treatment strategies for patients with these cancers. The project focuses on individuals who have not yet begun chemotherapy or biological therapies, allowing for the assessment of these innovative diagnostic tools in a clinical setting. The overarching goal is to enhance cancer management and patient outcomes through better diagnostic methodologies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of breast or lung cancer who have not yet started chemotherapy or biological therapies.
Not a fit: Patients under 18 years old, pregnant women, or those with a history of other malignancies or terminal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of breast and lung cancers, potentially improving treatment outcomes for patients.
How similar studies have performed: While the approach of using non-invasive blood tests for cancer diagnosis is gaining traction, the specific methodologies being developed in this study are novel and have not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Lecce
- Asl Lecce — Lecce, Italy (RECRUITING)
Study contacts
- Study coordinator: Prisco Piscitelli, Medical Doctor
- Email: dreamfazzi@gmail.com
- Phone: 0039 0832 661111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer Risk, Breast Cancer Risk, Lung Cancer