Recruiting

Observational Study

Sponsor:

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Code:

NCT07903532

Conditions

Tumor Burden

Neuroendocrine (NE) Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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).

Conditions

Tumor Burden

Neuroendocrine (NE) Tumors

Study ID

NCT07903532

Start date

May 12, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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. ]

Central Contacts and Locations

Central contacts

Angela Lamarca, MD, PhD

+34 915504800angela.lamarca@quironsalud.es

Diego Fernández, MD

+34 636284882diego.fernandezr@quironsalud.es

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jennifer Chan, MD

617-632-3000jennifer_chan@dfci.harvard.edu

Mallinckrodt Institute of Radiology

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Prasad Vikas, MD

314-362-1474pvikas@wustl.edu

More Information

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Tumor Burden
  • Neuroendocrine Tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.