Neuroendocrine Tumors Clinical Trial
— REBORNOfficial title:
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Andrea M Isidori | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Best 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. — View Citation
Fiedler U, Augustin HG. Angiopoietins: a link between angiogenesis and inflammation. Trends Immunol. 2006 Dec;27(12):552-8. Epub 2006 Oct 12. Review. — View Citation
Harris 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. — View Citation
Joosse 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. — View Citation
Monnier 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. Review. — View Citation
Sol 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the modification of the angiogenetic mediator sTie2 after treatment. | Modification of sTie (soluble Tie2) after treatment | baseline - + 1 month - +3 months | |
Secondary | To evaluate the difference in the angiogenetic mediator sTie2 between patients and controls | Comparison of basal levels of sTie between patients and controls | baseline | |
Secondary | To validate the use of circular RNAs from TEPs in NEN diagnosis | Validation of the use of circular RNAs sequencing from tumor educated platelets (TEPs) in NETs diagnosis, through the comparison between patients and controls | baseline | |
Secondary | To evaluate the changing in circular RNAs from TEPs in NEN patients after somatostatin analogs treatment | Modification in circular RNAs sequencing from tumor educated platelets (TEPs) in patients after treatment | baseline - + 1 month - +3 months | |
Secondary | To compare circular and cellular angiogenesis mediators between patients and controls | Comparison of basal level of other circular and cellular angiogenesis mediators between patients and controls (Angiogenic factors: ANG1, ANG2, FGF1, FGF2, NRP1, NRP2, VEGFA, VEGFB, VEGFC, HIF1A, NOS3, PROK1, PROK2; Cytokines: CCL11, CCL2, CXCL1, CXCL10, CXCL5, CXCL6, CXCL9, IL1B, IL6, TNF; Receptors and other angiogenic factors: VEGFR1, VEGFR2, TIE2, PDGFR, TGFBR, MMP14, MMP2, MMp9, TIMP1, TIMP2, TIMP3, PROKR1, PROKR2) | baseline | |
Secondary | To evaluate the changing in circular and cellular angiogenesis mediators after treatment. | Modification of other circular and cellular angiogenesis mediators in patients after treatment (Angiogenic factors: ANG1, ANG2, FGF1, FGF2, NRP1, NRP2, VEGFA, VEGFB, VEGFC, HIF1A, NOS3, PROK1, PROK2; Cytokines: CCL11, CCL2, CXCL1, CXCL10, CXCL5, CXCL6, CXCL9, IL1B, IL6, TNF; Receptors and other angiogenic factors: VEGFR1, VEGFR2, TIE2, PDGFR, TGFBR, MMP14, MMP2, MMp9, TIMP1, TIMP2, TIMP3, PROKR1, PROKR2) | baseline - + 1 month - +3 months | |
Secondary | To quantify PBMC subpopulation in patients and controls | Quatification of peripheral blood mononuclear cells (PBMC) subpopulations in patients and controls | baseline | |
Secondary | To evaluate the modification of PBMC subpopulation in patients after treatment | Modification of peripheral blood mononuclear cells (PBMC) subpopulations in patients after treatment | baseline - + 1 month - +3 months | |
Secondary | To compare classical neuroendocrine markers serum levels between patients and controls | Comparison of basal serum level of classical neuroendocrine markers (chromogranin a and neuron specific enolase) between patients and controls | baseline | |
Secondary | To evaluate the modification of classical neuroendocrine markers in patients after treatment | Modification of classical neuroendocrine markers (chromogranin a and neuron specific enolase) in patients after treatment | baseline - + 1 month - +3 months | |
Secondary | To evaluate infectious diseases frequency and severity between patients and controls | Frequencies and severity of infectious diseases will be evaluated by modified Infectious Diseases Questionnaire (GNC). This questionnaire includes questions on infectious diseases of upper and lower respiratory tract, gastrointestinal tract, skin and urogenital tract contracted during the previous 12 months. Questions investigate on the number and duration of infections, necessity of antibiotic or antifungal therapy, hospital stay and days of absence from work. Final score represents the frequency of infections. Moreover, some questions investigate possible susceptible or protective factors for infectious diseases: vaccinations, use of corticosteroids, concomitant diseases, previous appendectomy, tonsillectomy, adenoidectomy, splenectomy or thymectomy. | baseline | |
Secondary | To evaluate the difference in quality of life questionnaire in patients and controls | Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire. This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component).
Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state. |
baseline | |
Secondary | To evaluate the modification in quality of life questionnaire in patients after treatment | Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire. This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component).
Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state. |
baseline - + 1 month - +3 months |
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