Multicenter Study for External Validation of the TB-NET Score (TB-NET)
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).
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Angela Lamarca, MD, PhD
- Numero di telefono: 3146 +34 915504800
- Email: angela.lamarca@quironsalud.es
Backup dei contatti dello studio
- Nome: Diego Fernández, MD
- Numero di telefono: +34 636284882
- Email: diego.fernandezr@quironsalud.es
Luoghi di studio
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São Paulo
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São Paulo, São Paulo, Brasile, 01308-050
- Reclutamento
- Hospital Sírio-Libanês
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Contatto:
- Regis Franca, MD
- Numero di telefono: +55 11 3394-0200
- Email: regisfranca@gmail.com
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Clichy, Francia, 92110
- Reclutamento
- Hôpital Beaujon
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Contatto:
- Maxime Ronot, MD, PhD
- Numero di telefono: +33 1 40 87 50 00
- Email: maxime.ronot@gmail.com
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Bavaria
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Erlangen, Bavaria, Germania, 91054
- Reclutamento
- Universitätsklinikum Erlangen
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Contatto:
- Marianne Pavel, MD
- Numero di telefono: +49 9131 85-0
- Email: marianne.pavel@uk-erlangen.de
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Lombardy
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Milan, Lombardy, Italia, 20132
- Reclutamento
- IRCCS Ospedale San Raffaele
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Contatto:
- Massimo Falconi, MD
- Numero di telefono: +39 02 26431
- Email: falconi.massimo@hsr.it
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-688
- Reclutamento
- University Hospital in Kraków
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Contatto:
- Marta Opalinska, MD, PhD
- Numero di telefono: +48 12 400 10 00
- Email: mkal@vp.pl
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Cantabria
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Santander, Cantabria, Spagna, 39008
- Reclutamento
- Hospital Universitario Marqués de Valdecilla
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Contatto:
- Carlos Lopez, MD
- Email: clopez@humv.es
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Madrid
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Madrid, Madrid, Spagna, 28040
- Reclutamento
- Hospital Universitario Fundación Jiménez Díaz
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Contatto:
- Diego Fernández, MD
- Numero di telefono: +34 636284882
- Email: diego.fernandezr@quironsalud.es
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Reclutamento
- Dana-Farber Cancer Institute
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Contatto:
- Jennifer Chan, MD
- Numero di telefono: 617-632-3000
- Email: jennifer_chan@dfci.harvard.edu
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Skåne County
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Malmö, Skåne County, Svezia, 214 28
- Reclutamento
- Skåne University Hospital
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Contatto:
- Carl Fredrik Warfvinge, MD
- Numero di telefono: +46 40331000
- Email: carl_fredrik.warfvinge@med.lu.se
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Ankara
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Ankara, Ankara, Turchia (Türkiye), 06080
- Reclutamento
- Hacettepe University Hospitals
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Contatto:
- Murat Tuncel, MD
- Numero di telefono: +90 3123055000
- Email: murat.tuncel@hacettepe.edu.tr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: RETROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression-Free Survival (PFS)
Lasso di tempo: From treatment initiation until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 120 months.
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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.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Objective Response Rate (ORR)
Lasso di tempo: From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.
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Response rate defined by RECIST 1.1 |
From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.
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Overall Survival (OS)
Lasso di tempo: From treatment initiation until death from any cause or last follow-up, assessed up to 120 months.
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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.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of Grade 3-4 Adverse Events According to CTCAE
Lasso di tempo: From treatment initiation until treatment discontinuation or the last available safety assessment, assessed up to 120 months.
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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.
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Correlation of Chromogranin A, 5-HIAA, and Neuron-Specific Enolase Levels With TB-NET Score
Lasso di tempo: At baseline, prior to treatment initiation.
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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.
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Percentage of Patients With Positive Baseline 18F-FDG PET/CT According to TB-NET Score Risk Group
Lasso di tempo: At baseline, prior to treatment initiation.
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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.
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Incremental Prognostic Value of Tumor Growth Rate at 3 and 6 Months for Progression-Free Survival
Lasso di tempo: 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.
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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.
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Percentage of Patients With Positive Baseline 68Ga-SSTR PET/CT According to TB-NET Score Risk Group
Lasso di tempo: At baseline, prior to treatment initiation.
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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.
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Percentage of Patients With Positive Baseline Somatostatin Receptor Scintigraphy According to TB-NET Score Risk Group
Lasso di tempo: At baseline, prior to treatment initiation.
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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.
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EO016-26_FJD
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