Multicenter Study for External Validation of the TB-NET Score
TB-NET
Multicentric Study for External Validation of the TB-NET Score
TB-NET
Multicentric Study for External Validation of the TB-NET Score
Sponsor study identifier
observational
400
9 countries
11
Study Start
May 12, 2026
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a retrospective, observational, multicenter study aiming to externally validate the TB-NET Score in an independent cohort of patients with advanced well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) or lung carcinoids. The primary objective is to validate the prognostic value of the TB-NET Score for progression-free survival (PFS). Secondary objectives include the evaluation of overall survival (OS), objective response rate (ORR), grade 3-4 adverse events, biochemical and functional imaging correlates, and the potential additional prognostic value of tumor growth rate (TGR).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2026
Actual (reported)September 30, 2026
Actual (reported)October 29, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-Free Survival (PFS)
Progression-free survival, defined as the time from treatment initiation to documented disease progression. Patients without documented progression at the end of follow-up will be censored at the date of the last follow-up without progression.
From treatment initiation until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 120 months.
Objective Response Rate (ORR)
From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.
Overall Survival (OS)
From treatment initiation until death from any cause or last follow-up, assessed up to 120 months.
Incidence of Grade 3-4 Adverse Events According to CTCAE
From treatment initiation until treatment discontinuation or the last available safety assessment, assessed up to 120 months.
Correlation of Chromogranin A, 5-HIAA, and Neuron-Specific Enolase Levels With TB-NET Score
At baseline, prior to treatment initiation.
Percentage of Patients With Positive Baseline 18F-FDG PET/CT According to TB-NET Score Risk Group
At baseline, prior to treatment initiation.
Adult patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110, United States
Angela Lamarca, MD, PhD
Hospital Universitario Fundación Jiménez Díaz
First Submitted
September 30, 2026
First Posted
October 29, 2026
Study Start
May 12, 2026
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Life Following Excision of Neuroendocrine Tumors
Contact the study team to confirm eligibility.
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
Hôpital Beaujon
Clichy, 92110, France
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
University Hospital in Kraków
Krakow, Lesser Poland Voivodeship, 30-688, Poland
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Uppsala University Hospital
Uppsala, Uppsala County, 751 85, Sweden
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, 1011, Switzerland
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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