Trial · NCT07903532
Multicenter Study for External Validation of the TB-NET Score
NCT07903532, Recruiting, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Study for External Validation of the TB-NET Score. Trials, record NCT07903532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Study for External Validation of the TB-NET Score
- NCT number
- NCT07903532
- Status
- Recruiting
- Enrollment
- 400 participants, estimated
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Conditions
- Tumor Burden, Neuroendocrine (NE) Tumors
- First posted
- 2026-10-29
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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. |
| Secondary | Objective Response Rate (ORR) | From treatment initiation until disease progression or the last tumor response assessment, assessed up to 120 months. | Response rate defined by RECIST 1.1 |
| Secondary | Overall Survival (OS) | 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. |
| Other | Incidence of Grade 3-4 Adverse Events According to CTCAE | From treatment initiation until treatment discontinuation or the last available safety assessment, assessed up to 120 months. | 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. |
| Other | Correlation of Chromogranin A, 5-HIAA, and Neuron-Specific Enolase Levels With TB-NET Score | At baseline, prior to treatment initiation. | 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. |
| Other | Percentage of Patients With Positive Baseline 18F-FDG PET/CT According to TB-NET Score Risk Group | At baseline, prior to treatment initiation. | 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. |
| Other | Incremental Prognostic Value of Tumor Growth Rate at 3 and 6 Months for Progression-Free Survival | 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. | 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. |
| Other | Percentage of Patients With Positive Baseline 68Ga-SSTR PET/CT According to TB-NET Score Risk Group | At baseline, prior to treatment initiation. | 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. |
| Other | Percentage of Patients With Positive Baseline Somatostatin Receptor Scintigraphy According to TB-NET Score Risk Group | At baseline, prior to treatment initiation. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07903532
GET https://conductscience.org/api/trials/v1/NCT07903532/registered