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).
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Angela Lamarca, MD, PhD
- 电话号码：3146 +34 915504800
- 邮箱：angela.lamarca@quironsalud.es
研究联系人备份
- 姓名：Diego Fernández, MD
- 电话号码：+34 636284882
- 邮箱：diego.fernandezr@quironsalud.es
学习地点
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Ankara
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Ankara、Ankara、土耳其（türkiye）、06080
- 招聘中
- Hacettepe University Hospitals
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接触：
- Murat Tuncel, MD
- 电话号码：+90 3123055000
- 邮箱：murat.tuncel@hacettepe.edu.tr
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São Paulo
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São Paulo、São Paulo、巴西、01308-050
- 招聘中
- Hospital Sírio-Libanês
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接触：
- Regis Franca, MD
- 电话号码：+55 11 3394-0200
- 邮箱：regisfranca@gmail.com
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Bavaria
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Erlangen、Bavaria、德国、91054
- 招聘中
- Universitätsklinikum Erlangen
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接触：
- Marianne Pavel, MD
- 电话号码：+49 9131 85-0
- 邮箱：marianne.pavel@uk-erlangen.de
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Lombardy
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Milan、Lombardy、意大利、20132
- 招聘中
- IRCCS Ospedale San Raffaele
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接触：
- Massimo Falconi, MD
- 电话号码：+39 02 26431
- 邮箱：falconi.massimo@hsr.it
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Clichy、法国、92110
- 招聘中
- Hôpital Beaujon
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接触：
- Maxime Ronot, MD, PhD
- 电话号码：+33 1 40 87 50 00
- 邮箱：maxime.ronot@gmail.com
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Lesser Poland Voivodeship
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Krakow、Lesser Poland Voivodeship、波兰、30-688
- 招聘中
- University Hospital in Kraków
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接触：
- Marta Opalinska, MD, PhD
- 电话号码：+48 12 400 10 00
- 邮箱：mkal@vp.pl
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Skåne County
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Malmö、Skåne County、瑞典、214 28
- 招聘中
- Skåne University Hospital
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接触：
- Carl Fredrik Warfvinge, MD
- 电话号码：+46 40331000
- 邮箱：carl_fredrik.warfvinge@med.lu.se
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Massachusetts
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Boston、Massachusetts、美国、02215
- 招聘中
- Dana-Farber Cancer Institute
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接触：
- Jennifer Chan, MD
- 电话号码：617-632-3000
- 邮箱：jennifer_chan@dfci.harvard.edu
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Cantabria
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Santander、Cantabria、西班牙、39008
- 招聘中
- Hospital Universitario Marqués de Valdecilla
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接触：
- Carlos Lopez, MD
- 邮箱：clopez@humv.es
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Madrid
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Madrid、Madrid、西班牙、28040
- 招聘中
- Hospital Universitario Fundación Jiménez Díaz
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接触：
- Diego Fernández, MD
- 电话号码：+34 636284882
- 邮箱：diego.fernandezr@quironsalud.es
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
描述
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).
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
|---|
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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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS)
大体时间：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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Response Rate (ORR)
大体时间：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)
大体时间：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.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Grade 3-4 Adverse Events According to CTCAE
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
|
合作者和调查者
合作者
调查人员
- 首席研究员：Angela Lamarca, MD, PhD、Hospital Universitario Fundación Jiménez Díaz
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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