Multicenter Study for External Validation of the TB-NET Score (TB-NET)

November 10, 2026 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Multicentric Study for External Validation of the TB-NET Score

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a retrospective, observational, multicenter study designed to externally validate the TB-NET Score in an independent cohort of patients with advanced well-differentiated neuroendocrine tumors.

Eligible patients will include adults with histologically confirmed advanced well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) or typical or atypical lung carcinoids who have received systemic therapy. GEP-NETs may be grade 1, 2, or 3, provided that well-differentiated morphology is confirmed. Patients with poorly differentiated neuroendocrine carcinomas will be excluded.

The primary objective is to externally validate the prognostic value of the TB-NET Score for progression-free survival (PFS). Secondary objectives include the assessment of overall survival (OS), objective response rate (ORR), grade 3-4 adverse events, biochemical and functional imaging correlates, and evaluation of whether tumor growth rate (TGR) provides additional prognostic information for PFS.

A minimum of 200 patients is planned, with no predefined maximum sample size. Clinical, pathological, radiological, treatment, and outcome data will be retrospectively collected by participating centers and entered into a centrally coordinated electronic data capture system. Statistical analyses will be performed centrally by the Gastrointestinal Tumors Unit at Fundación Jiménez Díaz.

Only pseudonymized data will be shared for the purposes of the study. Data transfers between participating centers and the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (IIS-FJD) will be governed by appropriate data transfer agreements when required. The study has received approval from the Research Ethics Committee of Fundación Jiménez Díaz.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01308-050
        • Recruiting
        • Hospital Sírio-Libanês
        • Contact:
  • France
      • Clichy, France, 92110
        • Recruiting
        • Hôpital Beaujon
        • Contact:
  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-688
        • Recruiting
        • University Hospital in Kraków
        • Contact:
          • Marta Opalinska, MD, PhD
          • Phone Number: +48 12 400 10 00
          • Email: mkal@vp.pl
  • Spain
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:
  • Sweden
    • Skåne County
      • Malmö, Skåne County, Sweden, 214 28
  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06080
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients With Advanced Well-Differentiated NETs

Adult patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From treatment initiation until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 120 months.

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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.

Response rate defined by RECIST 1.1
From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.
Overall Survival (OS)
Time Frame: From treatment initiation until death from any cause or last follow-up, assessed up to 120 months.

The time from treatment initiation to death; patients alive at the end of follow up will be censored at the time of last follow up.
From treatment initiation until death from any cause or last follow-up, assessed up to 120 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Grade 3-4 Adverse Events According to CTCAE
Time Frame: From treatment initiation until treatment discontinuation or the last available safety assessment, assessed up to 120 months.

The proportion of patients experiencing at least one Grade 3 or 4 adverse event during treatment, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 adverse events are defined as severe, and Grade 4 adverse events as life-threatening.
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
Time Frame: At baseline, prior to treatment initiation.

The association between baseline biochemical marker levels, including chromogranin A (CgA), 5-hydroxyindoleacetic acid (5-HIAA), and neuron-specific enolase (NSE), and tumor burden assessed using the TB-NET Score will be evaluated. Correlations will be analyzed separately for each biomarker using appropriate statistical methods.
At baseline, prior to treatment initiation.
Percentage of Patients With Positive Baseline 18F-FDG PET/CT According to TB-NET Score Risk Group
Time Frame: At baseline, prior to treatment initiation.

The percentage of patients with positive baseline fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) will be calculated separately for the low-risk (TB-NET Score 1-2) and high-risk (TB-NET Score ≥3) groups. Imaging positivity will be assessed as a binary variable (positive versus negative) based on the imaging report. Only patients with available baseline 18F-FDG PET/CT results will be included. Unit of Measure: Percentage of patients.
At baseline, prior to treatment initiation.
Incremental Prognostic Value of Tumor Growth Rate at 3 and 6 Months for Progression-Free Survival
Time Frame: TGR assessed at 3 and 6 months after treatment initiation; subsequent PFS assessed from each landmark until disease progression or death from any cause, whichever occurs first, up to 120 months after treatment initiation.

The incremental prognostic value of tumor growth rate (TGR), assessed at 3 and 6 months after treatment initiation, will be evaluated for progression-free survival (PFS). TGR will be calculated using serial radiological tumor measurements and expressed as percentage tumor growth per month. Separate landmark analyses at 3 and 6 months will assess the association between TGR and subsequent PFS using Cox proportional hazards regression models, comparing the TB-NET Score alone with the TB-NET Score plus TGR.
TGR assessed at 3 and 6 months after treatment initiation; subsequent PFS assessed from each landmark until disease progression or death from any cause, whichever occurs first, up to 120 months after treatment initiation.
Percentage of Patients With Positive Baseline 68Ga-SSTR PET/CT According to TB-NET Score Risk Group
Time Frame: At baseline, prior to treatment initiation.

The percentage of patients with positive baseline gallium-68-labeled somatostatin receptor positron emission tomography/computed tomography (68Ga-SSTR PET/CT) will be calculated separately for the low-risk (TB-NET Score 1-2) and high-risk (TB-NET Score ≥3) groups. Imaging positivity will be assessed as a binary variable (positive versus negative) based on the imaging report. Only patients with available baseline 68Ga-SSTR PET/CT results will be included. Unit of Measure: Percentage of patients.
At baseline, prior to treatment initiation.
Percentage of Patients With Positive Baseline Somatostatin Receptor Scintigraphy According to TB-NET Score Risk Group
Time Frame: At baseline, prior to treatment initiation.

The percentage of patients with positive baseline somatostatin receptor scintigraphy (OctreoScan) will be calculated separately for the low-risk (TB-NET Score 1-2) and high-risk (TB-NET Score ≥3) groups. Imaging positivity will be assessed as a binary variable (positive versus negative) based on the imaging report. Only patients with available baseline OctreoScan results will be included. Unit of Measure: Percentage of patients.
At baseline, prior to treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Royal Marsden NHS Foundation Trust
Washington University School of Medicine
Hacettepe University
Dana-Farber Cancer Institute
UMC Utrecht
Beaujon Hospital
Royal Free Hospital NHS Foundation Trust
University of Lausanne Hospitals
Ospedale San Raffaele
Skane University Hospital
Hospital Sirio-Libanes
Uppsala University Hospital
Hospital Universitario Marqués de Valdecilla
Royal North Shore Hospital
University Hospital in Krakow
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
Instituto Alexander Fleming

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EO016-26_FJD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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