NCT02270567

RegisterNET - A Registry for Neuroendocrine Tumors in the USA and Worldwide

A Registry for Neuroendocrine Tumors

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Wren Laboratories LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Neuroendocrine tumors are derived from the neuroendocrine system of the gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery, medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at collecting data and blood samples from patients presenting with a NET. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry through prospective agreements and sub-study protocols with Wren Laboratories. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.

Detailed description

Background: Survival for neuroendocrine tumors is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. Non-invasive biomarkers have been identified that can improve diagnosis and prognosis of patients. Little, however, is known about the utility of these markers in clinical practice. Objective: To systematically and prospectively collect clinical information and blood samples for NETest from neuroendocrine tumors to evaluate the clinical validity of this biomarker for diagnosis, surveillance, and prediction of disease prognosis and response to targeted therapeutics. Methods: All neuroendocrine tumors (gastroenteropancreatic and pulmonary) are following informed consent. Data will be entered prospectively and anonymized. Patient history including a quality of life survey are completed by contributing physicians and blood sample is collected for analysis. All information will be transferred to the database. Evaluation of treatment modalities and patient outcomes (e.g. disease recurrence) will be assessed at follow-up times. The primary objectives of the project are to: * monitor patients with neuroendocrine tumors * provide descriptive statistical analyses * assessment of diagnostic accuracy of NETest The secondary objectives of the project include: * assessment of disease recurrence, progression and prognosis * analysis of patient survival Analyses will include: 1. Descriptive statistical analyses including demographics, site, treatment, QoL assessment. 2. Clinical follow-up and blood chemistry results. 3. Correlation analyses between blood results e.g., changes in NETest and clinical data. This will include assessment of the time at which the blood chemistry results significantly (and consistently) increases and the time of tumor recurrence and an evaluation whether the change in blood results is predictive of disease recurrence or progression. Changes can also be used for prognosis and evaluating response to therapies e.g., PRRT.

Conditions

• Neuroendocrine Tumor
• Carcinoid
• Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DEVICE	NETest	Non-invasive blood test

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-03-01
• Completion: 2030-12-01
• First posted: 2014-10-21
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States