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).
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Angela Lamarca, MD, PhD
- 電話番号：3146 +34 915504800
- メール：angela.lamarca@quironsalud.es
研究連絡先のバックアップ
- 名前：Diego Fernández, MD
- 電話番号：+34 636284882
- メール：diego.fernandezr@quironsalud.es
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- 募集
- Dana-Farber Cancer Institute
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コンタクト：
- Jennifer Chan, MD
- 電話番号：617-632-3000
- メール：jennifer_chan@dfci.harvard.edu
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Lombardy
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Milan、Lombardy、イタリア、20132
- 募集
- IRCCS Ospedale San Raffaele
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コンタクト：
- Massimo Falconi, MD
- 電話番号：+39 02 26431
- メール：falconi.massimo@hsr.it
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Skåne County
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Malmö、Skåne County、スウェーデン、214 28
- 募集
- Skåne University Hospital
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コンタクト：
- Carl Fredrik Warfvinge, MD
- 電話番号：+46 40331000
- メール：carl_fredrik.warfvinge@med.lu.se
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Cantabria
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Santander、Cantabria、スペイン、39008
- 募集
- Hospital Universitario Marqués de Valdecilla
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コンタクト：
- Carlos Lopez, MD
- メール：clopez@humv.es
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Madrid
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Madrid、Madrid、スペイン、28040
- 募集
- Hospital Universitario Fundación Jiménez Díaz
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コンタクト：
- Diego Fernández, MD
- 電話番号：+34 636284882
- メール：diego.fernandezr@quironsalud.es
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Ankara
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Ankara、Ankara、トルコ（Türkiye）、06080
- 募集
- Hacettepe University Hospitals
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コンタクト：
- Murat Tuncel, MD
- 電話番号：+90 3123055000
- メール：murat.tuncel@hacettepe.edu.tr
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Bavaria
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Erlangen、Bavaria、ドイツ、91054
- 募集
- Universitätsklinikum Erlangen
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コンタクト：
- Marianne Pavel, MD
- 電話番号：+49 9131 85-0
- メール：marianne.pavel@uk-erlangen.de
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Clichy、フランス、92110
- 募集
- Hôpital Beaujon
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コンタクト：
- Maxime Ronot, MD, PhD
- 電話番号：+33 1 40 87 50 00
- メール：maxime.ronot@gmail.com
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São Paulo
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São Paulo、São Paulo、ブラジル、01308-050
- 募集
- Hospital Sírio-Libanês
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コンタクト：
- Regis Franca, MD
- 電話番号：+55 11 3394-0200
- メール：regisfranca@gmail.com
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Lesser Poland Voivodeship
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Krakow、Lesser Poland Voivodeship、ポーランド、30-688
- 募集
- University Hospital in Kraków
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コンタクト：
- Marta Opalinska, MD, PhD
- 電話番号：+48 12 400 10 00
- メール：mkal@vp.pl
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
|---|
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠：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.
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Overall Survival (OS)
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Grade 3-4 Adverse Events According to CTCAE
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
協力者
捜査官
- 主任研究者：Angela Lamarca, MD, PhD、Hospital Universitario Fundación Jiménez Díaz
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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