External validation of the TB-NET score in advanced well‑differentiated neuroendocrine tumors
Official title: Multicentric Study for External Validation of the TB-NET Score
Run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT07903532 · Data updated 2026-11-12
This study tests whether the TB-NET score can predict progression-free survival in adults with advanced well-differentiated gastroenteropancreatic neuroendocrine tumors or lung carcinoids who have received systemic therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 11 sites (Boston, Massachusetts and 10 other locations) |
| Status | Recruiting |
| Started | May 12, 2026 |
| Main results expected | March 2027 |
| Study ends | September 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07903532 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed advanced well-differentiated GEP-NETs or typical/atypical lung carcinoids, who have started systemic therapy and have at least one target lesion.
✕Probably not a fit
Patients with poorly differentiated neuroendocrine carcinomas or those without measurable disease may not benefit from the TB-NET score validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective, multicenter observational study that will collect data from multiple international centers to externally validate the TB-NET score in an independent cohort. The primary goal is to see if the TB-NET score accurately predicts progression-free survival, with secondary analyses including overall survival, objective response rate, severe adverse events, and correlations with biochemical and imaging markers, as well as whether tumor growth rate adds prognostic value. Eligible participants are adults with histologically confirmed advanced well-differentiated GEP-NETs or typical/atypical lung carcinoids who have received systemic therapy and have at least one measurable lesion. Data will be pseudonymized and centrally analyzed, with a minimum planned sample size of 200, across sites in the U.S., Europe, and Brazil.
Why it matters
Potential benefit: If successful, the TB-NET score could help clinicians better stratify risk and tailor management for patients with advanced neuroendocrine tumors.
How similar studies have gone: External validation of prognostic scores in neuroendocrine tumors has shown variable success; this study aims to establish generalizability across independent cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy. * Grade 1, 2 or 3 if well-differentiated morphology for GEP-NETs. Typical or Atypical Lung Carcinoids. * At least one target lesion. Exclusion Criteria: * Patients with Neuroendocrine Carcinomas. * Patients with no target lesions (according to RECIST 1.1 criteria).
Where it's running
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States Recruiting -
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil Recruiting -
Hôpital Beaujon
Clichy, France Recruiting -
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany Recruiting -
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy Recruiting
Show 5 more locations
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University Hospital in Kraków
Krakow, Lesser Poland Voivodeship, Poland Recruiting -
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain Recruiting -
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain Recruiting -
Uppsala University Hospital
Uppsala, Uppsala County, Sweden Recruiting -
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, Switzerland Recruiting
Study contacts
- Principal investigator: Angela Lamarca, MD, PhD — Hospital Universitario Fundación Jiménez Díaz
- Study coordinator: Angela Lamarca, MD, PhD
- Email: angela.lamarca@quironsalud.es
- Phone: +34 915504800
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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.