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Trial · NCT04464122

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTo evaluate the modification of the angiogenetic mediator sTie2 after treatment.baseline - + 1 month - +3 monthsModification of sTie (soluble Tie2) after treatment
SecondaryTo evaluate the difference in the angiogenetic mediator sTie2 between patients and controlsbaselineComparison of basal levels of sTie between patients and controls
SecondaryTo validate the use of circular RNAs from TEPs in NEN diagnosisbaselineValidation of the use of circular RNAs sequencing from tumor educated platelets (TEPs) in NETs diagnosis, through the comparison between patients and controls
SecondaryTo evaluate the changing in circular RNAs from TEPs in NEN patients after somatostatin analogs treatmentbaseline - + 1 month - +3 monthsModification in circular RNAs sequencing from tumor educated platelets (TEPs) in patients after treatment
SecondaryTo compare circular and cellular angiogenesis mediators between patients and controlsbaseline
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)
SecondaryTo evaluate the changing in circular and cellular angiogenesis mediators after treatment.baseline - + 1 month - +3 months
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)
SecondaryTo quantify PBMC subpopulation in patients and controlsbaselineQuatification of peripheral blood mononuclear cells (PBMC) subpopulations in patients and controls
SecondaryTo evaluate the modification of PBMC subpopulation in patients after treatmentbaseline - + 1 month - +3 monthsModification of peripheral blood mononuclear cells (PBMC) subpopulations in patients after treatment
SecondaryTo compare classical neuroendocrine markers serum levels between patients and controlsbaselineComparison of basal serum level of classical neuroendocrine markers (chromogranin a and neuron specific enolase) between patients and controls
SecondaryTo evaluate the modification of classical neuroendocrine markers in patients after treatmentbaseline - + 1 month - +3 monthsModification of classical neuroendocrine markers (chromogranin a and neuron specific enolase) in patients after treatment
SecondaryTo evaluate infectious diseases frequency and severity between patients and controlsbaseline
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.
SecondaryTo evaluate the difference in quality of life questionnaire in patients and controlsbaseline
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.
SecondaryTo evaluate the modification in quality of life questionnaire in patients after treatmentbaseline - + 1 month - +3 months
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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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