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).
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Angela Lamarca, MD, PhD
- Número de teléfono: 3146 +34 915504800
- Correo electrónico: angela.lamarca@quironsalud.es
Copia de seguridad de contactos de estudio
- Nombre: Diego Fernández, MD
- Número de teléfono: +34 636284882
- Correo electrónico: diego.fernandezr@quironsalud.es
Ubicaciones de estudio
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Bavaria
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Erlangen, Bavaria, Alemania, 91054
- Reclutamiento
- Universitätsklinikum Erlangen
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Contacto:
- Marianne Pavel, MD
- Número de teléfono: +49 9131 85-0
- Correo electrónico: marianne.pavel@uk-erlangen.de
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São Paulo
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São Paulo, São Paulo, Brasil, 01308-050
- Reclutamiento
- Hospital Sírio-Libanês
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Contacto:
- Regis Franca, MD
- Número de teléfono: +55 11 3394-0200
- Correo electrónico: regisfranca@gmail.com
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Cantabria
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Santander, Cantabria, España, 39008
- Reclutamiento
- Hospital Universitario Marqués de Valdecilla
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Contacto:
- Carlos Lopez, MD
- Correo electrónico: clopez@humv.es
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Madrid
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Madrid, Madrid, España, 28040
- Reclutamiento
- Hospital Universitario Fundación Jiménez Díaz
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Contacto:
- Diego Fernández, MD
- Número de teléfono: +34 636284882
- Correo electrónico: diego.fernandezr@quironsalud.es
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Reclutamiento
- Dana-Farber Cancer Institute
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Contacto:
- Jennifer Chan, MD
- Número de teléfono: 617-632-3000
- Correo electrónico: jennifer_chan@dfci.harvard.edu
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Clichy, Francia, 92110
- Reclutamiento
- Hôpital Beaujon
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Contacto:
- Maxime Ronot, MD, PhD
- Número de teléfono: +33 1 40 87 50 00
- Correo electrónico: maxime.ronot@gmail.com
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Lombardy
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Milan, Lombardy, Italia, 20132
- Reclutamiento
- IRCCS Ospedale San Raffaele
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Contacto:
- Massimo Falconi, MD
- Número de teléfono: +39 02 26431
- Correo electrónico: falconi.massimo@hsr.it
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-688
- Reclutamiento
- University Hospital in Kraków
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Contacto:
- Marta Opalinska, MD, PhD
- Número de teléfono: +48 12 400 10 00
- Correo electrónico: mkal@vp.pl
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Skåne County
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Malmö, Skåne County, Suecia, 214 28
- Reclutamiento
- Skåne University Hospital
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Contacto:
- Carl Fredrik Warfvinge, MD
- Número de teléfono: +46 40331000
- Correo electrónico: carl_fredrik.warfvinge@med.lu.se
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Ankara
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Ankara, Ankara, Turquía (Türkiye), 06080
- Reclutamiento
- Hacettepe University Hospitals
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Contacto:
- Murat Tuncel, MD
- Número de teléfono: +90 3123055000
- Correo electrónico: murat.tuncel@hacettepe.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression-Free Survival (PFS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Response Rate (ORR)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Grade 3-4 Adverse Events According to CTCAE
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EO016-26_FJD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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