Exploring new biomarkers for diagnosing and treating neuroendocrine tumors
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study
This study is testing new ways to diagnose and treat neuroendocrine tumors by looking at blood samples to see if they can provide better information about the cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT04464122 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study investigates new biomarkers, including immune profiling, angiogenetic markers, and circular RNAs from tumor-educated platelets (TEPs), to improve diagnosis and treatment response evaluation in patients with neuroendocrine neoplasms (NENs). The study aims to address the limitations of existing tumor markers by utilizing liquid biopsies, which may provide a less invasive method for cancer diagnostics. By analyzing immune cell profiles and TEPs, the research seeks to enhance understanding of the immune status in NEN patients and identify more effective diagnostic tools.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically-proven locally advanced or metastatic neuroendocrine neoplasms originating from the pulmonary or gastro-entero-pancreatic tract.
Not a fit: Patients with severe chronic kidney disease or significant respiratory, cardiological, or hepatobiliary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and earlier diagnosis of neuroendocrine tumors, improving treatment outcomes for patients.
How similar studies have performed: While the use of tumor-educated platelets and liquid biopsies is a novel approach in the NEN field, similar methodologies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group); * Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group). Exclusion Criteria: * Severe chronic kidney disease (stage 4-5); * Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease; * Other non-neuroendocrine malignancies.
Where this trial is running
Rome, Italy
- Andrea M Isidori — Rome, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea M Isidori, MD, PhD — Department of Experimental Medicine, Sapienza University of Rome
- Study coordinator: Andrea M Isidori, MD, PhD
- Email: andrea.isidori@uniroma1.it
- Phone: +390649970540
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.