Exploring new biomarkers for diagnosing and treating neuroendocrine tumors
Official title: Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study
Run by University of Roma La Sapienza · NCT04464122 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | September 14, 2020 |
| Main results expected | September 14, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | April 3, 2025 |
| Trial ID | NCT04464122 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically-proven locally advanced or metastatic neuroendocrine neoplasms originating from the pulmonary or gastro-entero-pancreatic tract.
✕Probably not a fit
Patients with severe chronic kidney disease or significant respiratory, cardiological, or hepatobiliary diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Investigating the impact of somatostatin analogues on tumor dose during radionuclide therapy
This study is testing if stopping or continuing long-acting somatostatin treatment affects how well radionuclide therapy works for adults with neuroendocrine tumors.
-
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This study is testing whether a lower dose of Everolimus can effectively treat patients with advanced neuroendocrine tumors while causing fewer side effects compared to a higher dose.
-
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This study is testing if a personalized dose of Lutetium-177 can improve treatment results for adults with hard-to-treat neuroendocrine tumors compared to standard treatment.
-
CTX-471 for NCAM-positive metastatic neuroendocrine tumors
A phase 2 trial is testing CTX-471 in adults with NCAM (CD56) positive metastatic neuroendocrine tumors that have progressed after standard therapy.
-
Testing a new treatment for advanced neuroendocrine tumors
This study is testing a new treatment combining a virus with two cancer drugs to see if it helps people with advanced neuroendocrine tumors feel better and tolerate the treatment well.
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Using a new type of PET scanner for imaging prostate cancer and related conditions
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.