Comparison of thymic, lung, and pancreatic well‑differentiated high‑grade neuroendocrine tumors
CLINical, Pathological and outcomE compArative Analysis Between, Thymic, pulmonaRy and Pancreatic Well Differentiated High Grade Neuroendocrine Tumors: a Retrospective Observational Study
This project will try to see if patients with advanced thymic, lung, or pancreatic well‑differentiated high‑grade neuroendocrine tumors (Ki‑67 >20%) are diagnosed and treated the same and whether tumor genetic changes relate to outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34 (estimated) |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT07429851 on ClinicalTrials.gov |
What this trial studies
The LINEAR study will create a retrospective single‑center database of about 34 patients with advanced well‑differentiated high‑grade neuroendocrine tumors (Ki‑67 >20%) from thymus, lung, and duodeno‑pancreas. Clinical records, imaging, treatment sequences, outcomes, and available tumor tissue for molecular profiling will be collected and harmonized. The primary aim is to compare diagnostic pathways and therapeutic algorithms across the three primary sites to test whether management differs in practice. Secondary analyses will correlate genomic alterations with treatment activity and patient outcomes in a hypothesis‑generating translational framework.
Who should consider this trial
Good fit: Adults with histologically confirmed well‑differentiated high‑grade NETs (Ki‑67 >20%) of the thymus, lung, or duodeno‑pancreas who have advanced disease, sufficient clinical records, and tumor tissue available for molecular analysis are the intended candidates.
Not a fit: Patients with poorly differentiated neuroendocrine carcinomas, low‑grade (G1/G2) NETs, mixed neuroendocrine‑non‑neuroendocrine neoplasms (MiNENs), other primary sites, or lacking adequate tissue or clinical follow‑up are unlikely to benefit from the study’s findings.
Why it matters
Potential benefit: If successful, the findings could help align treatment decision pathways for thymic and lung high‑grade NETs with pancreatic NET practice and improve treatment selection and outcomes for this rare group.
How similar studies have performed: Retrospective and molecular analyses have informed therapy sequencing in pancreatic NETs, but comparable evidence for thymic and well‑differentiated high‑grade lung NETs is sparse, making this a partly novel, hypothesis‑generating approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of well-differentiated high grade neuroendocrine tumor (Ki-67 \> 20% according to WHO 2022) performed or reviewed by a NEN-dedicated pathologist. * Primary tumor site:thyme, lung and duodenum-pancreas NETs. * Advanced stage of tumor disease and Any number of lines of therapy * Sufficient available clinical data on diagnosis, treatments, outcomes. Exclusion Criteria: * Poorly differentiated neuroendocrine carcinomas (NECs), GEP NET G1/G2, pulmonary carcinoid with Ki-67 \< 20%. * Diagnosis of mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) * Inadequate or unavailable tumor tissue for molecular analysis. * Incomplete clinical records or follow-up. * Other primary sites, except lung or pancreas.
Where this trial is running
Milan, Italy
- European Institute of Oncology — Milan, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Nicola Fazio, MD — Ieo
- Study coordinator: Cristiana Mulargiu, MD
- Email: divisione.gastrointestinale@ieo.it
- Phone: 00390257489258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.