Tumor BurdenTB-NETNCT07903532
Multicenter Study for External Validation of the TB-NET Score
An observational study of Tumor Burden and Neuroendocrine (NE) Tumors, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 11 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Burden, Neuroendocrine (NE) Tumors
- How many people
- 400 participants
- Where
- 11 sitesin 9 countries
- Study dates
- 12 May 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Who may be able to join
- 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.
Who cannot join
- Patients with Neuroendocrine Carcinomas.
- Patients with no target lesions (according to RECIST 1.1 criteria).
Trial locations and contacts
11 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 9 countries
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Jennifer Chan, MD, 617-632-3000, jennifer_chan@dfci.harvard.edu
- Recruiting
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110
Prasad Vikas, MD, 314-362-1474, pvikas@wustl.edu
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Diego Fernández, MD, +34 636284882, diego.fernandezr@quironsalud.es
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Carlos Lopez, MD, clopez@humv.es
Brazil1 site, 1 recruiting
- Recruiting
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050
Regis Franca, MD, +55 11 3394-0200, regisfranca@gmail.com
France1 site, 1 recruiting
- Recruiting
Hôpital Beaujon
Clichy, 92110
Maxime Ronot, MD, PhD, +33 1 40 87 50 00, maxime.ronot@gmail.com
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Marianne Pavel, MD, +49 9131 85-0, marianne.pavel@uk-erlangen.de
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Massimo Falconi, MD, +39 02 26431, falconi.massimo@hsr.it
Poland1 site, 1 recruiting
- Recruiting
University Hospital in Kraków
Krakow, Lesser Poland Voivodeship, 30-688
Marta Opalinska, MD, PhD, +48 12 400 10 00, mkal@vp.pl
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, Uppsala County, 751 85
Joakim Crona, MD, PhD, +46 18-611 00 00, joakim.crona@medsci.uu.se
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, 1011
Naik Vietti Violi, MD, +41 21 314 11 11, naik.vietti-violi@chuv.ch
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Tumor Burden, Neuroendocrine (NE) Tumors
- Keywords
- Tumor Burden, Neuroendocrine Tumors
- Medical subject headings
- Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: From treatment initiation until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 120 months.
Secondary outcomes (2)
Objective Response Rate (ORR)
Response rate defined by RECIST 1.1
Measured: From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.
Overall Survival (OS)
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.
Measured: From treatment initiation until death from any cause or last follow-up, assessed up to 120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start12 May 2026
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, Dana-Farber Cancer Institute, Royal North Shore Hospital, Hacettepe University, UMC Utrecht, INSTITUTO ALEXANDER FLEMING, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Hospital Universitario Marqués de Valdecilla, University Hospital in Krakow, Royal Free Hospital NHS Foundation Trust, Skane University Hospital, Royal Marsden NHS Foundation Trust, Uppsala University Hospital, Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen, Beaujon Hospital, Washington University School of Medicine, Hospital Sirio-Libanes, Ospedale San Raffaele
- Responsible party
- Sponsor
- Investigators
- Angela Lamarca, MD, PhD, Principal investigator, Hospital Universitario Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903532
- Sponsor's protocol ID
- EO016-26_FJD
- Acronym
- TB-NET
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study for External Validation of the TB-NET Score
- ClinicalTrials.gov ID
- NCT07903532
- Acronym / sponsor ID
- TB-NET / EO016-26_FJD
- Conditions
- Tumor Burden, Neuroendocrine (NE) Tumors
- Keywords
- Tumor Burden, Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, Dana-Farber Cancer Institute, Royal North Shore Hospital, Hacettepe University, UMC Utrecht, INSTITUTO ALEXANDER FLEMING, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Hospital Universitario Marqués de Valdecilla, University Hospital in Krakow, Royal Free Hospital NHS Foundation Trust, Skane University Hospital, Royal Marsden NHS Foundation Trust, Uppsala University Hospital, Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen, Beaujon Hospital, Washington University School of Medicine, Hospital Sirio-Libanes, Ospedale San Raffaele
- Study start
- 12 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed well differentiated advanced GEP-NETs or Lung Carcinoids starting any line of systemic therapy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with Neuroendocrine Carcinomas.
- Patients with no target lesions (according to RECIST 1.1 criteria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months.
Overall Survival (OS)
Time frame: From treatment initiation until death from any cause or last follow-up, assessed up to 120 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Lamarca, MD, PhD principal investigator
Hospital Universitario Fundación Jiménez Díaz
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Burden and Neuroendocrine (NE) Tumors, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 11 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Spain, Brazil, France, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Lamarca, MD, PhD (+34 915504800 ext. 3146, angela.lamarca@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From treatment initiation until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 120 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.