Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)
REBORN
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 3, 2025
March 1, 2025
5 years
July 3, 2020
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the modification of the angiogenetic mediator sTie2 after treatment.
Modification of sTie (soluble Tie2) after treatment
baseline - + 1 month - +3 months
Secondary Outcomes (12)
To evaluate the difference in the angiogenetic mediator sTie2 between patients and controls
baseline
To validate the use of circular RNAs from TEPs in NEN diagnosis
baseline
To evaluate the changing in circular RNAs from TEPs in NEN patients after somatostatin analogs treatment
baseline - + 1 month - +3 months
To compare circular and cellular angiogenesis mediators between patients and controls
baseline
To evaluate the changing in circular and cellular angiogenesis mediators after treatment.
baseline - + 1 month - +3 months
- +7 more secondary outcomes
Study Arms (2)
Neuroendocrine toumor group
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.
Control group
Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (18-80 years, males and females)
Interventions
According to current ENETS guidelines, patients will be treated by somatostatin analogs or chemotherapy, recommended respectively as first line therapy in neuroendocrine tumours or neuroendocrine neoplasms.
Eligibility Criteria
Patients with histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic tract
You may qualify if:
- 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).
You may not qualify if:
- Severe chronic kidney disease (stage 4-5);
- Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;
- Other non-neuroendocrine malignancies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrea M Isidori
Rome, Italy, 00161, Italy
Related Publications (6)
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.
PMID: 28681241BACKGROUNDJoosse 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: 26555171BACKGROUNDFiedler 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: 17045842BACKGROUNDMonnier 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: 20633984BACKGROUNDBest 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: 26525104BACKGROUNDHarris 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: 11448916BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea M Isidori, MD, PhD
Department of Experimental Medicine, Sapienza University of Rome
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 9, 2020
Study Start
September 14, 2020
Primary Completion
September 14, 2025
Study Completion
December 31, 2025
Last Updated
April 3, 2025
Record last verified: 2025-03