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).
Przegląd badań
Status
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Angela Lamarca, MD, PhD
- Numer telefonu: 3146 +34 915504800
- E-mail: angela.lamarca@quironsalud.es
Kopia zapasowa kontaktu do badania
- Nazwa: Diego Fernández, MD
- Numer telefonu: +34 636284882
- E-mail: diego.fernandezr@quironsalud.es
Lokalizacje studiów
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São Paulo
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São Paulo, São Paulo, Brazylia, 01308-050
- Rekrutacyjny
- Hospital Sírio-Libanês
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Kontakt:
- Regis Franca, MD
- Numer telefonu: +55 11 3394-0200
- E-mail: regisfranca@gmail.com
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Clichy, Francja, 92110
- Rekrutacyjny
- Hôpital Beaujon
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Kontakt:
- Maxime Ronot, MD, PhD
- Numer telefonu: +33 1 40 87 50 00
- E-mail: maxime.ronot@gmail.com
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Cantabria
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Santander, Cantabria, Hiszpania, 39008
- Rekrutacyjny
- 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, Hiszpania, 28040
- Rekrutacyjny
- Hospital Universitario Fundación Jiménez Díaz
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Kontakt:
- Diego Fernández, MD
- Numer telefonu: +34 636284882
- E-mail: diego.fernandezr@quironsalud.es
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Bavaria
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Erlangen, Bavaria, Niemcy, 91054
- Rekrutacyjny
- Universitätsklinikum Erlangen
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Kontakt:
- Marianne Pavel, MD
- Numer telefonu: +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, Polska, 30-688
- Rekrutacyjny
- University Hospital in Kraków
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Kontakt:
- Marta Opalinska, MD, PhD
- Numer telefonu: +48 12 400 10 00
- E-mail: mkal@vp.pl
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Rekrutacyjny
- Dana-Farber Cancer Institute
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Kontakt:
- Jennifer Chan, MD
- Numer telefonu: 617-632-3000
- E-mail: jennifer_chan@dfci.harvard.edu
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Skåne County
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Malmö, Skåne County, Szwecja, 214 28
- Rekrutacyjny
- Skåne University Hospital
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Kontakt:
- Carl Fredrik Warfvinge, MD
- Numer telefonu: +46 40331000
- E-mail: carl_fredrik.warfvinge@med.lu.se
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Ankara
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Ankara, Ankara, Turcja (Türkiye), 06080
- Rekrutacyjny
- Hacettepe University Hospitals
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Kontakt:
- Murat Tuncel, MD
- Numer telefonu: +90 3123055000
- E-mail: murat.tuncel@hacettepe.edu.tr
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Lombardy
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Milan, Lombardy, Włochy, 20132
- Rekrutacyjny
- IRCCS Ospedale San Raffaele
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Kontakt:
- Massimo Falconi, MD
- Numer telefonu: +39 02 26431
- E-mail: falconi.massimo@hsr.it
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: RETROSPECTIVE
Kohorty i interwencje
Grupa / 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Progression-Free Survival (PFS)
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Objective Response Rate (ORR)
Ramy czasowe: 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)
Ramy czasowe: 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.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Grade 3-4 Adverse Events According to CTCAE
Ramy czasowe: 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.
|
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Correlation of Chromogranin A, 5-HIAA, and Neuron-Specific Enolase Levels With TB-NET Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EO016-26_FJD
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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