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).
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Angela Lamarca, MD, PhD
- Número de telefone: 3146 +34 915504800
- E-mail: angela.lamarca@quironsalud.es
Estude backup de contato
- Nome: Diego Fernández, MD
- Número de telefone: +34 636284882
- E-mail: diego.fernandezr@quironsalud.es
Locais de estudo
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Bavaria
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Erlangen, Bavaria, Alemanha, 91054
- Recrutamento
- Universitätsklinikum Erlangen
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Contato:
- Marianne Pavel, MD
- Número de telefone: +49 9131 85-0
- E-mail: marianne.pavel@uk-erlangen.de
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São Paulo
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São Paulo, São Paulo, Brasil, 01308-050
- Recrutamento
- Hospital Sírio-Libanês
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Contato:
- Regis Franca, MD
- Número de telefone: +55 11 3394-0200
- E-mail: regisfranca@gmail.com
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Cantabria
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Santander, Cantabria, Espanha, 39008
- Recrutamento
- Hospital Universitario Marqués de Valdecilla
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Contato:
- Carlos Lopez, MD
- E-mail: clopez@humv.es
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Madrid
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Madrid, Madrid, Espanha, 28040
- Recrutamento
- Hospital Universitario Fundación Jiménez Díaz
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Contato:
- Diego Fernández, MD
- Número de telefone: +34 636284882
- E-mail: diego.fernandezr@quironsalud.es
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Recrutamento
- Dana-Farber Cancer Institute
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Contato:
- Jennifer Chan, MD
- Número de telefone: 617-632-3000
- E-mail: jennifer_chan@dfci.harvard.edu
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Clichy, França, 92110
- Recrutamento
- Hôpital Beaujon
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Contato:
- Maxime Ronot, MD, PhD
- Número de telefone: +33 1 40 87 50 00
- E-mail: maxime.ronot@gmail.com
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Lombardy
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Milan, Lombardy, Itália, 20132
- Recrutamento
- IRCCS Ospedale San Raffaele
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Contato:
- Massimo Falconi, MD
- Número de telefone: +39 02 26431
- E-mail: falconi.massimo@hsr.it
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polônia, 30-688
- Recrutamento
- University Hospital in Kraków
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Contato:
- Marta Opalinska, MD, PhD
- Número de telefone: +48 12 400 10 00
- E-mail: mkal@vp.pl
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Skåne County
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Malmö, Skåne County, Suécia, 214 28
- Recrutamento
- Skåne University Hospital
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Contato:
- Carl Fredrik Warfvinge, MD
- Número de telefone: +46 40331000
- E-mail: carl_fredrik.warfvinge@med.lu.se
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Ankara
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Ankara, Ankara, Turquia (Türkiye), 06080
- Recrutamento
- Hacettepe University Hospitals
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Contato:
- Murat Tuncel, MD
- Número de telefone: +90 3123055000
- E-mail: murat.tuncel@hacettepe.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: RETROSPECTIVE
Coortes e Intervenções
Grupo / 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response Rate (ORR)
Prazo: 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)
Prazo: 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.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Grade 3-4 Adverse Events According to CTCAE
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EO016-26_FJD
Plano para dados de participantes individuais (IPD)
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