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).
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Angela Lamarca, MD, PhD
- Telefonní číslo: 3146 +34 915504800
- E-mail: angela.lamarca@quironsalud.es
Studijní záloha kontaktů
- Jméno: Diego Fernández, MD
- Telefonní číslo: +34 636284882
- E-mail: diego.fernandezr@quironsalud.es
Studijní místa
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São Paulo
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São Paulo, São Paulo, Brazílie, 01308-050
- Nábor
- Hospital Sírio-Libanês
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Kontakt:
- Regis Franca, MD
- Telefonní číslo: +55 11 3394-0200
- E-mail: regisfranca@gmail.com
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Clichy, Francie, 92110
- Nábor
- Hôpital Beaujon
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Kontakt:
- Maxime Ronot, MD, PhD
- Telefonní číslo: +33 1 40 87 50 00
- E-mail: maxime.ronot@gmail.com
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Lombardy
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Milan, Lombardy, Itálie, 20132
- Nábor
- IRCCS Ospedale San Raffaele
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Kontakt:
- Massimo Falconi, MD
- Telefonní číslo: +39 02 26431
- E-mail: falconi.massimo@hsr.it
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Bavaria
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Erlangen, Bavaria, Německo, 91054
- Nábor
- Universitätsklinikum Erlangen
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Kontakt:
- Marianne Pavel, MD
- Telefonní číslo: +49 9131 85-0
- E-mail: marianne.pavel@uk-erlangen.de
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polsko, 30-688
- Nábor
- University Hospital in Kraków
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Kontakt:
- Marta Opalinska, MD, PhD
- Telefonní číslo: +48 12 400 10 00
- E-mail: mkal@vp.pl
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Nábor
- Dana-Farber Cancer Institute
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Kontakt:
- Jennifer Chan, MD
- Telefonní číslo: 617-632-3000
- E-mail: jennifer_chan@dfci.harvard.edu
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Ankara
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Ankara, Ankara, Turecko (Türkiye), 06080
- Nábor
- Hacettepe University Hospitals
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Kontakt:
- Murat Tuncel, MD
- Telefonní číslo: +90 3123055000
- E-mail: murat.tuncel@hacettepe.edu.tr
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Cantabria
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Santander, Cantabria, Španělsko, 39008
- Nábor
- Hospital Universitario Marqués de Valdecilla
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Kontakt:
- Carlos Lopez, MD
- E-mail: clopez@humv.es
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Madrid
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Madrid, Madrid, Španělsko, 28040
- Nábor
- Hospital Universitario Fundación Jiménez Díaz
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Kontakt:
- Diego Fernández, MD
- Telefonní číslo: +34 636284882
- E-mail: diego.fernandezr@quironsalud.es
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Skåne County
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Malmö, Skåne County, Švédsko, 214 28
- Nábor
- Skåne University Hospital
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Kontakt:
- Carl Fredrik Warfvinge, MD
- Telefonní číslo: +46 40331000
- E-mail: carl_fredrik.warfvinge@med.lu.se
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: RETROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival (PFS)
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Objective Response Rate (ORR)
Časové okno: 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)
Časové okno: 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.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Grade 3-4 Adverse Events According to CTCAE
Časové okno: 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
Časové okno: 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.
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Percentage of Patients With Positive Baseline 18F-FDG PET/CT According to TB-NET Score Risk Group
Časové okno: 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
Časové okno: 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.
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Percentage of Patients With Positive Baseline 68Ga-SSTR PET/CT According to TB-NET Score Risk Group
Časové okno: 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.
|
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Percentage of Patients With Positive Baseline Somatostatin Receptor Scintigraphy According to TB-NET Score Risk Group
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EO016-26_FJD
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