Clinical trial · Observational
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study
NCT04464122CI-TRIAL-00088063REBORNrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Neoplasm | Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumor Grade 1 | Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor G2 | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somatostatin analog; chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Neuroendocrine toumor group
- description
- 30 patients (18-80 years, males and females) affected by histologically-proven neuroendocrine neoplasms, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to medical therapy.
- interventionNames
- Drug: Somatostatin analog; chemotherapy
- label
- Control group
- description
- Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (18-80 years, males and females)
Primary outcomes (1)
- measure
- To evaluate the modification of the angiogenetic mediator sTie2 after treatment.
- timeFrame
- baseline - + 1 month - +3 months
- description
- Modification of sTie (soluble Tie2) after treatment
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group); * Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group). Exclusion Criteria: * Severe chronic kidney disease (stage 4-5); * Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease; * Other non-neuroendocrine malignancies.
References
Publications (6)
- BACKGROUNDSol N, Wurdinger T. Platelet RNA signatures for the detection of cancer. Cancer Metastasis Rev. 2017 Jun;36(2):263-272. doi: 10.1007/s10555-017-9674-0. PMID 28681241
- BACKGROUNDJoosse SA, Pantel K. Tumor-Educated Platelets as Liquid Biopsy in Cancer Patients. Cancer Cell. 2015 Nov 9;28(5):552-554. doi: 10.1016/j.ccell.2015.10.007. PMID 26555171
- BACKGROUNDFiedler U, Augustin HG. Angiopoietins: a link between angiogenesis and inflammation. Trends Immunol. 2006 Dec;27(12):552-8. doi: 10.1016/j.it.2006.10.004. Epub 2006 Oct 12. PMID 17045842
- BACKGROUNDMonnier J, Samson M. Prokineticins in angiogenesis and cancer. Cancer Lett. 2010 Oct 28;296(2):144-9. doi: 10.1016/j.canlet.2010.06.011. Epub 2010 Jul 14. PMID 20633984
- BACKGROUNDBest MG, Sol N, Kooi I, Tannous J, Westerman BA, Rustenburg F, Schellen P, Verschueren H, Post E, Koster J, Ylstra B, Ameziane N, Dorsman J, Smit EF, Verheul HM, Noske DP, Reijneveld JC, Nilsson RJA, Tannous BA, Wesseling P, Wurdinger T. RNA-Seq of Tumor-Educated Platelets Enables Blood-Based Pan-Cancer, Multiclass, and Molecular Pathway Cancer Diagnostics. Cancer Cell. 2015 Nov 9;28(5):666-676. doi: 10.1016/j.ccell.2015.09.018. Epub 2015 Oct 29. PMID 26525104
- BACKGROUNDHarris AL, Reusch P, Barleon B, Hang C, Dobbs N, Marme D. Soluble Tie2 and Flt1 extracellular domains in serum of patients with renal cancer and response to antiangiogenic therapy. Clin Cancer Res. 2001 Jul;7(7):1992-7. PMID 11448916