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).
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Angela Lamarca, MD, PhD
- 전화번호: 3146 +34 915504800
- 이메일: angela.lamarca@quironsalud.es
연구 연락처 백업
- 이름: Diego Fernández, MD
- 전화번호: +34 636284882
- 이메일: diego.fernandezr@quironsalud.es
연구 장소
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Bavaria
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Erlangen, Bavaria, 독일, 91054
- 모병
- Universitätsklinikum Erlangen
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연락하다:
- Marianne Pavel, MD
- 전화번호: +49 9131 85-0
- 이메일: marianne.pavel@uk-erlangen.de
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- 모병
- Dana-Farber Cancer Institute
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연락하다:
- Jennifer Chan, MD
- 전화번호: 617-632-3000
- 이메일: jennifer_chan@dfci.harvard.edu
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São Paulo
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São Paulo, São Paulo, 브라질, 01308-050
- 모병
- Hospital Sírio-Libanês
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연락하다:
- Regis Franca, MD
- 전화번호: +55 11 3394-0200
- 이메일: regisfranca@gmail.com
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Skåne County
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Malmö, Skåne County, 스웨덴, 214 28
- 모병
- Skåne University Hospital
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연락하다:
- Carl Fredrik Warfvinge, MD
- 전화번호: +46 40331000
- 이메일: carl_fredrik.warfvinge@med.lu.se
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Cantabria
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Santander, Cantabria, 스페인, 39008
- 모병
- Hospital Universitario Marqués de Valdecilla
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연락하다:
- Carlos Lopez, MD
- 이메일: clopez@humv.es
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Madrid
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Madrid, Madrid, 스페인, 28040
- 모병
- Hospital Universitario Fundación Jiménez Díaz
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연락하다:
- Diego Fernández, MD
- 전화번호: +34 636284882
- 이메일: diego.fernandezr@quironsalud.es
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Lombardy
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Milan, Lombardy, 이탈리아, 20132
- 모병
- IRCCS Ospedale San Raffaele
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연락하다:
- Massimo Falconi, MD
- 전화번호: +39 02 26431
- 이메일: falconi.massimo@hsr.it
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06080
- 모병
- Hacettepe University Hospitals
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연락하다:
- Murat Tuncel, MD
- 전화번호: +90 3123055000
- 이메일: murat.tuncel@hacettepe.edu.tr
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, 폴란드, 30-688
- 모병
- University Hospital in Kraków
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연락하다:
- Marta Opalinska, MD, PhD
- 전화번호: +48 12 400 10 00
- 이메일: mkal@vp.pl
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Clichy, 프랑스, 92110
- 모병
- Hôpital Beaujon
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연락하다:
- Maxime Ronot, MD, PhD
- 전화번호: +33 1 40 87 50 00
- 이메일: maxime.ronot@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: RETROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS)
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR)
기간: 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)
기간: 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.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Grade 3-4 Adverse Events According to CTCAE
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Angela Lamarca, MD, PhD, Hospital Universitario Fundación Jiménez Díaz
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EO016-26_FJD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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