RegisterNET - A Registry for Neuroendocrine Tumors in the USA
Conditions
Neuroendocrine Tumor - Carcinoid - Neuroendocrine Carcinoma
Conditions: official terms
Apudoma - Carcinoid Tumor - Carcinoma, Neuroendocrine - Neuroendocrine Tumors
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: NETest
Type: Device
Overall Status
Recruiting
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 in the USA. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry. 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 from neuroendocrine tumors in the USA based a histologically confirmed diagnosis.

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 molecular-based blood tests

The secondary objectives of the project include:

- assessment of disease recurrence

- 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 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
Criteria: Inclusion Criteria:

- Gastroenteropancreatic neuroendocrine tumor

- Bronchopulmonary neuroendocrine tumor

- Gastroenteropancreatic neuroendocrine carcinoma

- Patient provides informed consent

Exclusion Criteria:

- N/A
Location
Wren Laboratories
Branford, Connecticut, United States
Status: Recruiting
Contact: Nancy Smith-Teixeira, MS (Nursing) - 855-295-8410 - nancy@wrenlaboratories.com
Start Date
February 2015
Completion Date
March 2020
Sponsors
Wren Laboratories LLC
Source
Wren Laboratories LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page