Clinical trial Recruiting at 1 site Observational Ages 18 to 80

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 typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Rome, Italy)
StatusRecruiting
StartedSeptember 14, 2020
Main results expectedSeptember 14, 2025
Study endsDecember 31, 2025
Registry record updatedApril 3, 2025
Trial IDNCT04464122 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.